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SNBL: Director of Safety Assessment, Everett, WA

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SNBL (Shin Nippon Biomedical Laboratories, Ltd)


Job Title: Director, Safety Assessment
Company: SNBL (Shin Nippon Biomedical Laboratories, Ltd)
Location: Everett, WA
Job Type: Full-Time

For more than 55 years, SNBL (Shin Nippon Biomedical Laboratories, Ltd) has been a leader in helping biopharmaceutical companies generate high quality data with the exceptional precision needed to rapidly advance new medical therapies and innovations that improve patients™ lives, SNBL has facilities in Japan, the United States, China, and Cambodia. Our international footprint enables us to meet the research needs of clients around the globe. We are committed to providing our customers with fast and precise results across the entire drug development spectrum, from early discovery research to late-stage clinical trials.

The SNBL team is dedicated as a company and as individuals in working with our clients to improve patient care and treatment outcomes. This is a cornerstone in our drive for excellence across all aspects of our business.

The Director of Safety Assessment is responsible for directing the Safety Assessment department to ensure the attainment of operational excellence and profit goals. Participates with the Executive Management Team in formulating current and long-range plans, objectives and policies. Ensures that the departmental policies, objectives and operation and communication network of the company supports the highest level of compliance and efficiency possible.

Responsibilities:
• Leads the Good Laboratory Practices (GLP) compliance initiatives. Oversees the development and implementation of strategic plans, policies and procedures to ensure department programs will meet or exceed internal and external customers™ needs and expectations.
• Assures the development, review, revision and implementation of SOPs, SSPs, Policies, Training Manuals and/or Checklists relating to technical procedures, facility issues, and data generation.
• Provides administrative approval of protocols.
• Directs and approves departmental resources, personnel, fiscal assignments and allocations.
• Designates Study Director, Principal Scientist, Contributing Scientist and Principal Investigator to meet Study objectives.
• Assigns Study Staff as appropriate to meet Study objectives.
• Acts as company representative to regulatory agencies, including the FDA, and local regulatory agencies.
• Ensures departmental managers are compliant with corporate directives.
• Plans and directs activities to ensure operational efficiency and economy.
• Plans, develops and manages budgets to meet or exceed department(s) and company goals.
• In conjunction with administrative personnel, reviews activity, operating, and budget reports to guide and direct programs or operations as required.
• Replaces the Study Director and Principal Investigator promptly if it becomes necessary to do so during the conduct of a study.
• Manages Study Directors, Study Supervisors, and Study Coordinators in Safety Assessment.
• Is responsible for the overall direction, coordination, and evaluation of the department.
• Approves department purchase orders and requests.
• Initiates and responds to client inquiries regarding company policy and procedures.
• Other duties as assigned.
• Carries out supervisory responsibilities in accordance with the organization\'s policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

Requirements
• Ph.D. in relevant biomedical field, MD, DVM, Masters or BS degree in combination with appropriate training and experience.*Minimum of seven years experience in evaluating pharmaceutical preclinical safety and toxicology studies in the pharmaceutical/biotech industry, in contract toxicology research organizations or similar organizations. Previous experience in management or supervision of groups or teams. A minimum of 5 years experience in conducting, developing and managing preclinical safety and efficacy programs. Experience in writing and presenting preclinical safety reports to support regulatory submissions.
• At least 8 years related experience and/or training; or equivalent combination of education and experience in industry / contract research organization (CRO) drug development.
• 3-5 years related experience
• DABT is desirable
• Advanced computer skills required.
• Ability to read, analyze and interpret scientific and technical journals, financial reports, and legal documents; the ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community; the ability to write speeches and articles for publication that conform to prescribed style and format. Excellent written and verbal communication skills including the ability to create and present high quality scientific presentations.
• Ability to apply advanced mathematical and statistical evaluations to scientific and business data for interpretation and presentation to staff and upper management.
• Requirements include training in GLP regulations and knowledge of ongoing toxicology, regulatory, laws, rules and notices on guidelines concerning preclinical drug development and business communication. Continual GLP training.
• Demonstrated ability to lead people and get results through others. Ability to organize and manage multiple priorities. Problem analysis and problem resolution at both a strategic and functional level.

For more information about SNBL USA and to apply for this position please go to https://careers-snblusa.icims.com/.

Apply Here: http://www.Click2Apply.net/gcr5vnp

An equal opportunity employer, M/F/D/V.

Please reference BioTechPharmJobs.com when responding.


Grifols: Donor Processor, Lakewood, CO

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Grifols


Job Title: Donor Processor
Company: Grifols
Location: Lakewood, CO
Job Type: Full-Time

We're Grifols, a $3 billion plasma manufacturer headquartered in Barcelona, Spain. Founded in 1940 with 11,000 employees worldwide, we're the largest manufacturer of plasma-derived therapies in Europe and the third largest in the United States. We serve healthcare professionals and patients in over 90 countries, have an unmatched record of product safety, and are the largest plasmapheresis company in the world.

A commitment to Grifols will provide you with a career path that you can build upon and be proud of. Our products make an incredible difference in saving people's lives and in improving the health and well-being of people around the world and are used in everything from chemotherapy applications to stem cell transplantation, hemophilia, primary immunodeficiencies, and even Alzheimer's research, all of which depend on blood-derived plasma therapy. In addition, despite our size and scope of operations, our plasma centers pride themselves on our "small company" and "family-like" culture. We're dedicated to and motivated by our mission of saving lives along with our intense focus on quality and giving back to the community. And a career at Grifols offers stable schedules and day-time hours, an entrepreneurial opportunity to grow into center and potentially regional and general management roles, and a work-life balance that values your time with your family and friends. Grifols also has internal education programs that are certified for continued education credits. So you can expect a fast-paced work environment, defined role structure, and lower-risk protocols.

And that's just the beginning. . . We also offer benefit-eligible employees and their families full healthcare benefits, including dental, vision, and life insurance as well as a Traditional and/or ROTH 401(k) plan with match. Tuition reimbursement is available, and some of our Academy courses even count for university credit! If you enjoy providing knock-your-socks-off customer service in a fast-paced healthcare environment built around teamwork and trust, then consider furthering your career as an Donor Processor and please read on . . .

Responsibilities:
• Conducts pre-donation medical screening in accordance with established guidelines
• Determines Hematocrit (HCT) and Protein via finger stick and use of the hematastat and refractometer
• Provides appropriate feedback to ineligible donor candidates
• Ensures all donor screening information is complete and accurate prior to donation
• Effectively communicates donor medical information to Medical Staff
• Ensures donor confidentiality
• Establishes and maintains donor files in an organized and efficient manner
• Builds rapport with donors to ensure overall customer satisfaction with the center to support long-term donation
• Performs general administrative duties, including greeting donors in a friendly manner, answering phones, and assisting center management as needed
• Learns and maintains through familiarity and compliance with all state and federal regulations, U.S. Food and Drug Administration (FDA)-approved Standard Operating Procedure Manual, Occupational Safety and Health Administration (OSHA), Clinical Laboratory Improvement Amendments (CLIA), Current Good Manufacturing Practice (cGMP) and internal company procedures
• Maintains supplies necessary to perform job duties
• Maintains and ensures proper sanitation and cleaning of equipment and work areas between donors
• Reports all unsafe situations or conditions to area lead, supervisor or manager

And as a Donor Processor at Grifols, you'll be trained in the areas of state and federal regulations regarding the Food and Drug Administration (FDA), Occupational Safety and Health Administration (OSHA), Clinical Laboratory Improvement Amendments (CLIA), and Current Good Manufacturing Practice (cGMP).

Job Requirements
• High school diploma, GED, or foreign equivalency required
• Prior knowledge of or experience working with state and federal healthcare regulations a plus
• [OPTIONAL: Bilingual Spanish/Korean/Mandarin skills desirable]

For More Information

There's much more learn about us, of course, and you can find additional information on our www.grifolsusa.com website. There's so much to share with you in the recruitment process, and we hope you're as excited as we are about Grifols Plasma Operation's potential to save lives and grow careers. Thank you for considering Grifols as your employer of choice.

Note that certain state licensures or certifications may apply. In addition, please understand that you'll be working in a plasma center, which includes exposure to biological fluids with potential exposure to infectious organisms. Personal protective equipment may be required, which will be provided at the company's expense.

Work is performed in a plasma center. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to electrical office and laboratory equipment. Exposure to extreme cold below 32*. Personal protective equipment required such as protective eyewear, garments and gloves. Work is performed standing for 6-8 hours per day. Repetitive foot movements, bends and twists neck and waist for 4-6 hours per day. Occasionally walks. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Light to moderate lifting of 15-30lbs. Heavy lifting of 30-45lbs. for 2-4 hours per day with a maximum lift of 50lbs. May reach above and below shoulder height. Hearing acuity essential. Color perception/discrimination, near vision and far vision correctable in one eye to 20/30 and to 20/100 in the other eye. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Performs simple and repetitive tasks that vary little each day by following a set of written or oral instructions/procedures. Maintains work pace to meet production standards.

Apply Now!

Please click on the following link to apply now. Grifols is an Equal Opportunity Employer, and we look forward to hearing from you.

The Grifols Recruitment Team

To apply online, please click here.

An equal opportunity employer, M/F/D/V.

Please reference BioTechPharmJobs.com when responding.


Grifols: Center Manager, Lakewood, CO

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Grifols


Job Title: Center Manager
Company: Grifols
Location: Lakewood, CO
Job Type: Full-Time

We're Grifols, a $3 billion plasma manufacturer headquartered in Barcelona, Spain. Founded in 1940 with 11,000 employees worldwide, we're the largest manufacturer of plasma-derived therapies in Europe and the third largest in the United States. We serve healthcare professionals and patients in over 90 countries, have an unmatched record of product safety, and are the largest plasmapheresis company in the world.

We're seeking a Center Manager for our Lakewood, Colorado Plasma Donation Center.

Responsibilities:
• Acts as the general manager for a Plasma Collection Center and has overall responsibility for the center's operation
• Works under general occasional guidance and general oversight of regional management
• Manages the daily operations of the center, supervising operations and quality control, and ensuring compliance with all applicable policies and regulations
• Responsible for meeting quarterly goals, staffing/hours per labor efficiency standards/cost per liter (CPL) targets and Quality key performance indicators (KPI) goals
• Create appropriate organizational environment and value systems which stimulate the morale and productivity of the work force and its leadership
• Operates the center and manages employees and operations to the highest standard of ethics and integrity
• Manages staff to ensure that training and quality goals are met and to implement operational changes and maximize center efficiency
• Directs and manages employees
• Monitor and evaluate operations
• Develop action plans to maximize center efficiency and supervise the implementation of process improvements
• Manages headcount to provide for efficient staffing through high and low production intervals, providing accurate and timely projections to regional management team in advance of cyclical and seasonal or situational spikes
• Accountable for the direction of all personnel functions including hiring, assignment and direction of work, development and training, disciplinary actions and termination and the maintenance of all personnel records
• Provides strategic direction and planning

Other Responsibilities for role:
• Acts as a mentor to assigned team, other center staff and other centers
• Through Assistant Manager, oversees donor selection, plasma collection and shipment and records completion
• Accountable to insure the adequate training of production employees and demonstrate how tasks are to be performed to meet company standards
• Accountable for the adequacy of inventory of all goods and supplies necessary for center operations and oversee ordering goods as needed
• Assure center employees maintain the facility in a neat and clean condition and all equipment is kept in good working order
• Accountable for freezer management, including overseeing plasma shipments and equipment failures
• Required to answer all freezer alarms and deal with them appropriately
• Submit timely and accurate reports on a daily/weekly basis or as requested
• Develop community representation with regards to all public relations and marketing campaigns to attract and retain donors
• Maintains thorough familiarity and ensures compliance with state and federal regulations, U.S. Food and Drug Administration (FDA)-approved Standard Operating Procedures, Occupational Safety and Health Administration (OSHA), Clinical Laboratory Improvement Amendments (CLIA), and Current Good Manufacturing Practice (cGMP)
• Accountable for donor selection, plasma collection and all manufacturing records to maintain the highest production standards in accordance with state and federal regulations, U.S. Food and Drug Administration (FDA)-approved Standard Operating Procedures, Occupational Safety and Health Administration (OSHA), Clinical Laboratory Improvement Amendments (CLIA), and Current Good Manufacturing Practice (cGMP)
• Directs through the management team and with Training and Quality staff to ensure that training and quality goals are met
• Builds rapport with donors to ensure overall customer satisfaction with the center to support long-term donation
• Works with Divisional/Corporate management in the preparation of annual budget and manages facility to consistently achieve production targets and quality goals at the agreed-upon cost structure
• Control center donor funds and ensure that all financial records are accurate and in order
• Identifies regulatory deficiencies and in collaboration with the Center Quality Manager implements immediate corrective action
• Minimize center liability through constant risk management review
• Investigates all unsafe situations and complaints and institutes corrective/preventive action
• Establishes and maintains the ability to perform all tasks within the center; fulfills the role of production employees when the occasional need arises
• Assumes Regional management oversight and mentoring duties for select facilities/projects or in ROMs absence
• Performs other duties as required

This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.

Job Requirements
• Bachelor's degree or equivalent, preferably in Science, Business, Nursing, Finance, or related field
• Typically requires a minimum of 3 years of related experience in clinical or general business experience
• Supervisory experience preferred but not required
• Prior management experience, preferably supervising a group of 20 or more employees
• Experience in a medical and/or cGMP regulated environment preferred
• Experience with plasma or whole blood preferred
• Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements
• If a job level requires a Bachelor's degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate's degree with 6 years of experience, or a Master's degree with 2 years of experience
• Command of leadership, management, presentation, organizational, customer service, interpersonal communication, and computer skills
• Ability to understand, assess and communicate FDA regulations
• Ability to balance multiple competing priorities, ensure proper staffing levels, maintain adequate levels of plasma collection, and adhere to quality standards
• Ability to control costs and maintain a budget
• Ability to motivate staff to achieve established goals and standards
• Ability to develop positive relationships with donors, center employees, and company employees working in different geographical locations
• Developing command of and proficiency in at least one functional area, such as finance, IT, HR, or compliance
• Ability to relocate preferred

An experienced Assistant Manager with a strong desire for success, excellent customer service skills, self-sufficient and marketing experience highly preferred.

Developing command of leadership, organizational, customer service, interpersonal communication, and computer abilities. Ability to understand and assess FDA regulations. Ability to maintain adequate levels of plasma collection and adhere to quality standards. Ability to motivate staff to achieve established goals and standards.

Occupational Demands: Work is performed in an office and/or a laboratory/manufacturing environment. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to electrical office equipment. Exposure to extreme cold below 32 degrees, miscellaneous production chemicals, moving machinery and production equipment. Exposure to high levels of noiseon production floor. Personal protective equipment required such as protective eyewear, garments and gloves. Frequently sits for 6-8 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Occasionally walks. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 35lbs. Frequently drives to site locations with occasional travel within the United States.Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Frequently interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues. Ability to apply abstract principles to solve complex conceptual issues.

Apply Now!

Please click on the following link to apply now. Grifols is an Equal Opportunity Employer, and we look forward to hearing from you.

The Grifols Recruitment Team

To apply online, please click here.

An equal opportunity employer, M/F/D/V.

Please reference BioTechPharmJobs.com when responding.


Grifols: Experienced Assistant Manager, Denver, CO

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Grifols


Job Title: Experienced Assistant Manager
Company: Grifols
Location: Denver, CO
Job Type: Full-Time

We're Grifols, a $3 billion plasma manufacturer headquartered in Barcelona, Spain. Founded in 1940 with 11,000 employees worldwide, we're the largest manufacturer of plasma-derived therapies in Europe and the third largest in the United States. We serve healthcare professionals and patients in over 90 countries, have an unmatched record of product safety, and are the largest plasmapheresis company in the world.

We are seeking an Experienced Assistant Manager for our new Denver, CO Plasma Center.

Responsibilities:
• Responsible for all aspects of the donor center when the Center Manager is not present
• Creates appropriate organizational environment and value systems which stimulate the morale and productivity of the work force and its leadership
• Collaborates with Training and Quality staff to ensure that training and quality goals are met
• Coaches and leads through effective feedback to employees through the Operations Supervisor(s)
• Monitors and evaluates operations
• Works with the Center Manager to develop action plans to maximize center efficiency and supervises the implementation of improvements
• Makes critical decisions for the modifications of action plans
• Responsible for all personnel functions including hiring, assignment and direction of work, development and training, disciplinary actions and termination and the maintenance of all personnel records
• Directs the training activities of production employees through the Training Coordinator
• Partners with the center manager in budget preparation and oversees facility to achieve production targets and quality goals at the agreed-upon cost structure
• Review and approve employee schedules to accommodate donor cycles
• Actively delegates, monitors and holds responsible the operations supervisors for their performance
• Directs and supervises employees
• Determine the adequacy and adjust inventory levels of all goods and supplies necessary of the operation of the donor center
• Compile and submit orders to vendors to meet determined inventory levels
• Assure center employees maintain the facility in a neat and clean condition and all equipment is kept in good working order
• Responsible for freezer management, including overseeing plasma shipments and equipment failures
• Required to answer all freezer alarms and deal with them appropriately
• Construct and submit timely and accurate reports on a daily/weekly/monthly or as required basis
• Develop and implement active donor recruitment advertising campaigns to improve production levels
• Maintains thorough familiarity and ensures compliance with state and federal regulations, U.S. Food and Drug Administration (FDA)-approved Standard Operating Procedures, Occupational Safety and Health Administration (OSHA), Clinical Laboratory Improvement Amendments (CLIA), and Current Good Manufacturing Practice (cGMP)
• Direct key personnel in donor selection, plasma collection and all manufacturing records to maintain the highest production standards in accordance with state and federal regulations, U.S. Food and DruAdministration (FDA)-approved Standard Operating Procedures, Occupational Safety and Health Administration (OSHA), Clinical Laboratory Improvement Amendments (CLIA), and Current Good Builds rapport with donors to ensure overall customer satisfaction with the center to support long-term donation
• Control center donor funds and ensure that all financial records are accurate and in order
• Keep Center Manager informed of any irregularities within the center and provide action plans to improve and correct center deficiencies
• Minimize center liability through constant risk management review
• Investigates all unsafe situations and Situations/complaints
• Develops and implements required corrective actions
• Directs and monitors the performance of outside vendors
• Review and monitor special projects for accuracy and timely completion
• Works with the Center Manager in implementing the donor center\'s mission into the community
• Performs other duties as required

This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.

Job Requirements
• Bachelor's degree or equivalent, preferably in Science, Business, Nursing, Finance, or related field
• ExperienceTypically requires 2 years of related experience in clinical or general business experience
• Supervisory experience preferred
• Experience in a medical and/or cGMP regulated environment preferred
• Experience with plasma or whole blood preferred

An experienced Assistant Manager with a strong desire for success, excellent customer service skills, self-sufficient and marketing experience highly preferred.

Developing command of leadership, organizational, customer service, interpersonal communication, and computer abilities. Ability to understand and assess FDA regulations. Ability to maintain adequate levels of plasma collection and adhere to quality standards. Ability to motivate staff to achieve established goals and standards.

Occupational Demands: Work is performed in an office and/or a laboratory/manufacturing environment. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to electrical office equipment. Exposure to extreme cold below 32 degrees, miscellaneous production chemicals, moving machinery and production equipment. Exposure to high levels of noise on production floor. Personal protective equipment required such as protective eyewear, garments and gloves. Frequently sits for 6-8 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Occasionally walks. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 35 lbs. Frequently drives to site locations with occasional travel within the United States.Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Frequently interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues. Ability to apply abstract principles to solve complex conceptual issues.

Apply Now!

Please click on the following link to apply now. Grifols is an Equal Opportunity Employer, and we look forward to hearing from you.

The Grifols Recruitment Team

To apply online, please click here.

An equal opportunity employer, M/F/D/V.

Please reference BioTechPharmJobs.com when responding.


 

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