Entries tagged with “cGMP” from BiotechPharmJobs.com

Job Description:

Job Title: QC Associate I
Location: South San Francisco, CA
Recruiting Firm: Q Analysts

Q Analysts is looking for an QC Associate I for one of its client's located in South San Francisco, CA.

Responsibilities:

• Sharing responsibilities for routine lab operation and maintance.
• Perform general wet chemistry assays such as pH determination, total organic carbon (TOC), and protein concentration by UV spec scan and endotoxin detection by LAL testing.
• Routine support of the Quality Control sample management process.
• Daily duties and responsibilities would include sample receipt from manufacturing, log in, verification, sample handling and internal transfer within QC.

Skills:

• Ability to work well with others in a positive and collaborative manner. Computer literacy and experience working in a cGMP environment are preferred, but not required.
• Understanding of analytical techniques cited above is required.
Education:

• BS/BA in Biochemistry, Chemistry or related field

To apply, please send your MS Word resume along with salary requirements to:
mmathews@qanalysts.com

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

Please reference BioTechPharmJobs.com when responding.

Job Description:

Job Title: Sr. Tech Manager
Location: South San Francisco, CA
Recruiting Firm: Q Analysts

Q Analysts is looking for an Sr. Tech Manager for one of its client's located in South San Francisco, CA.

The purpose of this position is to provide quality oversight and expertise for the selection, implementation and management of manufacture of small molecule API and Drug Product at contract manufacturing organizations.

Responsibilities:

• Build strong relationships with both internal operations units and external CMOs and partners.
• Participate in due diligence visits to assess CMO's Quality Systems for processing of investigational / commercial medicinal products.
• Negotiate and maintain Quality Agreements with selected CMOs and ensure the requirements of the Quality Agreement are fulfilled. Ensure product-specific requirements are met.
• Ensure that manufacture and testing of clinical supplies of the client's small molecule & ADC products at contract manufacturing organizations (CMOs) is conducted in accordance with cGMP.
• Follow up on any corrective actions identified as a result of the client's audits.
• Write and execute CMO facility/process GMP commissioning plans to ensure all quality requirements are met prior to manufacturing.
• Review and approve master batch records for compliance to clinical trial protocols, regulatory filings, pertinent product requirements and cGMP compliance.
• Perform person-in-the-plant activities as required during GMP manufacturing.
• Review batch records and assess deviations and investigations.
• Review CMC sections of regulatory filings.
• Participate in the design, implementation and maintenance of quality systems for small molecules for execution of the above functions.

Skills:

• Demonstrated working knowledge of Quality Assurance and manufacturing principles.
• Sound knowledge of US cGMPs and an ability to apply sound judgment and decision-making skills in order to evaluate product release is necessary.
• Working knowledge of worldwide cGMP regulations desired.
• Excellent written and verbal communication skills.
• Strong interpersonal skills and negotiation skills.

Education:

• At least 5 to 10 years relevant pharmaceutical experience with small molecules, experience in solid dosage form manufacturing is desired.
• At least 4 years direct experience in quality assurance for pharmaceutical operations.
• BS/BA in a relevant scientific discipline or equivalent

To apply, please send your MS Word resume along with salary requirements to:
mmathews@qanalysts.com

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

Please reference BioTechPharmJobs.com when responding.

Job Description:

Job Title: Associate Director
Location: South San Francisco, CA
Recruiting Firm: Q Analysts

Q Analysts is looking for an Associate Director for one of its client's located in South San Francisco, CA.

Responsibilities:

• Accountable for the development and deployment of the External Quality strategy for the selection and operation of Contract Manufacturing Organizations (CMO) that support the global Small Molecule product development effort at Roche (PTD, pRed and gRed).
• Accountable for all aspects of Quality related to these CMO's to include: Quality Systems, Product Quality Operations, Assay Qualification and Validation, cGMP Compliance, Risk Management, and Inspection Readiness.
• Responsible for ensuring that all GMP activities are in the best interest of the patients, comply with global regulations and uphold Roche's reputation as a reliable, high quality supplier of IMP products.
• In collaboration with other PTx, gRed and pRed functions, ensures appropriate measures are employed to fulfill the requirements of phase appropriate cGMPs, international standards and requirements.
• Responsible for management of risk, through proactive risk management tools and approaches for each CMO within the Roche Small Molecule Development Network.
• Accountable for the management of Quality and Compliance within the External Quality Small Molecule Development group to include: staffing, talent management, performance management, financial performance, and execution to meet strategic and operational objectives.

Skills:

• Minimum 12 years of direct work experience in the pharmaceutical industry.
• Demonstrated leadership experience in a Pharmaceutical Development environment.
• Strong knowledge of cGMP and Quality requirements for various early and late phase clinical stages.
• Experience technical aspects of pharmaceutical manufacture (Starting materials, API, Solid Dosage Form, and Packaging).
• Experience in reviewing and approving IND, IMPD and NDA documentation for submission to health authorities.
• Demonstrated leadership and execution of Quality Operations and processes. Established track record of Quality and Compliance decision-making.
• International experience working with ex-US manufacturing, EU QP's, and ROW cGMP Sophisticated negotiation and influencing skills.
• Strong leadership and communication skills.

Education:

• Minimum BS degree. MS, PhD in chemistry or chemical engineering.

To apply, please send your MS Word resume along with salary requirements to:
mmathews@qanalysts.com

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

Please reference BioTechPharmJobs.com when responding.

Job Description:

Job Title: Manufacturing Technician
Location: Haverhill, MA

Responsible for producing innovative biotherapeutic medicine by interfacing with highly automated production systems and controls in cGMP manufacturing environment, and maintain areas in high state of inspection preparedness. Operate production equipment for cell culture or purification that may include culture growth, process monitoring, sampling, harvesting and purification. Perform media/buffer solution preparation operations. Maintain records and clean room environment to comply with regulatory requirements utilizing current Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOP).

Responsible for being proficient in one or more functional areas. Understands and applies biological, chemical and mechanical principles and techniques.

Job Responsibilities
Essential
• Operate systems that clean and sterilize tanks and filtration systems.
• Prepare solutions for the production process.
• Review documentation and check all calculations (e.g. tickets, labels, equipment reading).
• Trouble shoot equipment and process problems.
• Comply with safety requirements, cGMP, SOP and manufacturing documentation.
• Use of automation to perform production operations.
• Provide support to Manufacturing to meet production demands.
• Operate automated systems for equipment operation.
• Assemble and prepare equipment for production.
• Exhibit detail oriented documentation skills
• Communicate effectively and ability to work in a team environment.
• Exhibit professional interpersonal skills.
• Work with coworkers and supervisor to effectively troubleshoot minor equipment and process issues.
• Follow established safety and environmental guidelines and procedures for all work performed. Immediately reports safety and environmental incidents including injuries, illnesses, near misses, and safety suggestions. Foster a positive safety culture in which no one gets hurt.

Job Matrix
• A good working knowledge of biopharmaceutical technology and processes.
• Trained and skilled in all operational procedures of at least one manufacturing department.
• Demonstrated ability to independently document and record information related to the process.
• Occasionally makes routine decisions based on experience. Identifies and suggests solutions to common basic problems.
• Recognizes non-routine problems, investigates and suggests potential solutions.
• Judgment is required in resolving problems and making routine recommendations.
• Ability to recognize deviation from accepted practices is required.

Supplementary Responsibilities
• Operate fermenters, centrifuges, other harvest systems and protein purifications units.
• Operate and clean fixed tank and filtration systems
• Operate large scale column chromatography systems.
• Operate small-scale cell culture areas and systems by operating cleaning, set up, and maintaining 20L batch feed fermenters; inoculating and maintaining spinner seed cultures using aseptic techniques, maintaining cell banks; and performing general seed lab operations, Column packing, chrome skid operations UFDF operation, bulk fill and purification.
• Perform Solution Preparation activities (media and buffer make-up)
• Clean, assemble, and sterilize equipment using glass washers and autoclaves.
• Perform automated CIP and SIP of fixed equipment.

Job Requirements
Education and Experience
• Degree in Life Sciences or engineering and 1 year related experience
• Or Associate Degree and 3 year experience
• Or High school and 5 years experience
• Biotech certificate from approved program

Knowledge, Skills, and Abilities
• Strong oral and written communication skills.
• Familiarity of computer-based systems
• Background in fermentation and purification
• SAP a plus
• Ability to receive, interpret and provide basic information and materials involved with the day to day activities of performing the job.

To apply, please send your MS Word resume along with salary requirements to:
lflynn@apollopros.com

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

Please reference BioTechPharmJobs.com when responding.

Job Description:

Job Title: Data Solutions Engineer
Location: San Francisco, CA
Length of Contract: 1 Year


eDynamic is looking for Data Solutions Engineer in San Francisco, CA. The Production Data Solutions Engineer is primarily responsible for designing, implementing and maintaining the Production information systems used to support FDA regulated biopharmaceutical manufacturing operations. The successful Consultant will:

• Lead the development of web-based data visualization tools using industry standard technologies such as ASP.NET, xMII, and Microsoft SharePoint.
• Provide tools to access manufacturing data from a variety of database and non-database sources to the entire Production Technology Group.
• Participate in the design, installation and testing of validated and non-validated computer information systems.
• Maintain manufacturing-related information systems, including data and batch historians, process dashboards, and provide technical support as needed.
• Ensure that work conforms to cGMP standards and all applicable codes and regulations from the CFR, Annex 11 and OSHA.

Requirements:

• 4+ years of Biotech/Pharma experience
• Knowledge of computer systems, relational databases, and experience utilizing Windows, the .NET Framework, PL/SQL, ASP.NET, C#, and/or relational databases to build software solutions.
• Experience with SAP, SAP xMII (formerly Light hammer), MES, InfoPlus.21, and IronSpeed software
• Working knowledge of SCADA software and programmable controllers for process control applications, redundant and high reliability computer and network hardware systems, programming language experience, or an understanding of biopharmaceutical process manufacturing.

To apply, please send your MS Word resume along with salary requirements to:
birendra.kumar@edynamic.net

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.