BioTech Pharma Jobs: January 2008 Archives

Supports the organization's mission, vision, and values by exhibiting the following behaviors: excellence and competence, collaboration, innovation, respect personalization, commitment to our community, and accountability and ownership.

POSITION SUMMARY:
The Quality Control Analyst I is a vital position in the Quality systems approach. The QC Analyst I will be responsible for chemical evaluation and testing of final product, intermediate products, stability samples and raw materials. Will assure ship schedules and contract testing requirements are met.

PRINCIPLE DUTIES AND RESPONSIBILITIES:
• Perform all chemical evaluation and testing of final product, intermediate products, stability samples and raw materials.
• Performing QC assays.
• Maintenance and calibration of all laboratory equipment.
• Preparation of solutions and solvents as needed.
• Responsible for monitoring and maintaining reagents needed for testing requirements.
• Will be required to perform other duties as requested, directed or assigned.

QUALIFICATIONS/SKILLS & KNOWLEDGE REQUIREMENTS
• 0-3 years Pharmaceutical experience or related field.
• BS degree in chemistry or a related field.
• Has knowledge of commonly used practices and procedures within a particular field.
• Computer skills proficient in use of e-mail, Access, Word, and Excel.
• Experienced in the use of High Performance Liquid Chromatographs (HPLC), UV, Dissolution apparatus, IR, GC, wet chemistry, as well as microbiological testing are desirable.
• Willing to learn and adapt to a changing environment, which may include new job assignments or special projects.
• Oral and written communication skills, strong interpersonal skills, and superior organizational abilities.
• Ability to take initiative, to maintain confidentiality, to meet deadlines, and to work in a team environment is essential.
• Relies on instructions and pre-established guidelines to perform the functions of the job.

GENERAL INFORMATION:
The above statements are intended to describe the general nature and level of work being performed by individuals assigned to this position. They are not intended to be an exhaustive list of all duties, responsibilities, and skills required of personnel so classified.

The incumbent must be able to work in a fast-paced environment with demonstrated ability to juggle and prioritize multiple, competing tasks and demands and to seek supervisory assistance as appropriate.

Incumbents within this position may be required to assist or find appropriate assistance to make accommodations for disabled individuals in order to ensure access to the organization's services (may include: visitors, patients, employees, or others).

Physical Demands:
Regularly required to sit or stand, reach, bend and move about the production facility and lifting of moderately heavy items such as test equipment kits and product cases. Working around moving machines in production facility, and the handling and testing of food grade chemicals. Other physical demands include climbing, crouching, and reaching. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Personal Protective Equipment:
• Respirator (Dust) Masks, Lab coats, gloves, sleeve protectors, steel toe shoes, etc.

Work Environment:
Work performed in an laboratory/office environment which involves moderate risks or discomforts that will require special safety precautions, e.g., working around moving machines in production facilities, handling and testing of food grade chemicals as well as hazardous materials (reagents used in the laboratory). The work environment described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

If you are interested in joining a team of professionals who are making a difference in the health of others, please contact Red River Pharma. Red River Pharma LLC offers a competitive compensation package and the satisfaction of belonging to a dynamic and vibrant health sciences organization.

For consideration, please mail/fax your resume indicating position of interest, to:

Red River Pharma LLC
Attn: Human Resources
PO Box 3723
Shreveport, LA 71133

Fax 318-678-8367

email: pnetherton@redriverpharma.com

An equal opportunity employer, m/f/d/v.

Please reference BioTechPharmJobs.com when responding.

Process Development Scientist - Protein Purification

Urgent requirement for one of our top clients located in Redwood City, CA.

Description:
The position will require hands-on work developing downstream processes, tech transfer of processes to CMOs and on- site interactions and management of CMOs to facilitate scale-up and clinical/commercial production. The incumbent will be responsible for developing, scaling up, & improving downstream processes in collaboration with external parties and the internally with the Protein Analysis group. The position requires the ability to develop and optimize downstream processes in accordance with regulatory requirements and the company's timelines for Phase III/commercialization. The individual will also be responsible for identification and implementation of improved technologies for R&D and commercial manufacture to enhance product quality, manufacturing cost efficiencies & regulatory compliance. The position is likely to require the management and training of junior staff.

Requirements:
Ph.D in Biochemistry or Biochemical Engineering with emphasis on Protein Purification and 5+ years of experience; or MS in Biochemistry or Biochemical Engineering with emphasis on Protein Purification and 10 plus years of relevant industrial experience. Experience in optimization and scale up of protein refolding from E. coli is a plus. Prior experience with various PEGylation methods at small and large scale is preferred.

Contact:
The most effective way of communication is via email please forward us your updated WORD FORMAT resume (Address, Contact number and email is must), including position of interest job No. PDS_1508, to *** anitha.maturi@makrotech.com ***

Please mention your best hourly rate, availability and visa status. Any questions, do feel free to email us.

An equal opportunity employer, m/f/d/v.

Please reference BioTechPharmJobs.com when responding.

Quality Assurance Manager

Urgent requirement for one of our top clients located in Emeryville, CA.

Description:
Perform a variety of activities to ensure compliance with applicable regulatory requirements and facilitate the management of third-party contract manufacturing organizations. Participate in the design, establishment and maintenance of programs and processes that ensure quality products and compliance with current Good Manufacturing Practices (cGMPs) for pharmaceutical, biotech and drug/device combination products. Author, edit, review, and approve policies, SOPs, and guidance documents. Manage and administer processes within the company's Quality System. Collaborate with functional groups and contract manufacturers to evaluate and address complex issues such as deviations, technical complaints, corrective and preventive action (CAPA) and failure investigations. May lead or coordinate investigations and corrective and preventive action (CAPA) recommendations related to products. Lead or assist compliance audits (GMP, GLP, GCP, Internal and Supplier/External). Work with R&D as QA representative during new product start-ups, and identify routine checkpoints for new products and processes. Contribute to the completion of CMC sections of regulatory submissions. Provide Quality oversight for the labeling, packaging, storage, and distribution of clinical trial materials.

Requirements:

Bachelor's or Master's Degree in a relevant scientific discipline with 5+ years demonstrated QA experience in a pharmaceutical or biotech company. Prior compliance work with sterile product, aseptic manufacturing processes, or drug/device combination products is highly desirable. Must have an understanding and application of FDA regulations and guidances, QA principles, concepts, industry practices, and standards.

Contact:
The most effective way of communication is via email please forward us your updated WORD FORMAT resume (Address, Contact number and email is must), including position of interest job No. QAM_1508, to *** anitha.maturi@makrotech.com ***

Please mention your best hourly rate, availability and visa status. Any questions, do feel free to email us.

An equal opportunity employer, m/f/d/v.

Please reference BioTechPharmJobs.com when responding.

Manager of BDMP, Quality and Training

Urgent requirement for one of our top clients located in Irvine, CA.

Position Description:
Develops and trains to BDMP SOPs, WIMs, training material and other controlled documents. Applies regulatory ICH, GCP, and ISO quality system requirements to ensure appropriate SOPs, WIMs, and processes are in place and are adequately controlled and implemented within BDMP. Responsibilities are as follows: Participates in the development, training, and maintenance of BDMP controlled documents to ensure global adherence to Good Clinical Practices (GCPs) and related regulations and guidelines. Acts as liaison on teams with other departments, such as Clinical Quality and Training, Clinical Research, RDSIS, WWQA, and Global Regulatory Compliance. Supports ISO-13485:2003 Certification Activities, including complying with WWQA standards, training BDMP, coordinating all preparatory activities within BDMP, participating in the audit and response.

Requirements:

A BS/BA degree, or equivalent experience, in a science, math, or computer science discipline, with an additional 8 years experience in a relevant field; or an MS degree, or equivalent experience, with an additional 6 years experience. A minimum of 4 years of experience directly related to a BDMP-technical area, or 2 years of experience directly related to a BDMP-technical area and 2 years of BDMP or Clinical GCP training experience.

Contact:
The most effective way of communication is via email please forward us your updated WORD FORMAT resume (Address, Contact number and email is must), including position of interest job No. MBQT_1108, to *** anitha.maturi@makrotech.com ***

Please mention your best hourly rate, availability and visa status. Any questions, do feel free to email us.

An equal opportunity employer, m/f/d/v.

Please reference BioTechPharmJobs.com when responding.