What are the responsibilities and job description for the Director- QC position at Abzena?
Job Summary:
The Director of Quality Control will have responsibility for the cGMP testing laboratories at the Bristol, PA contract manufacturing site. The laboratory provides support in a regulated environment guided by FDA and international requirements as applicable to product testing from investigational phase to commercial launch. The Director will oversee the activities of several managers, scientists and associate-level staff in the establishment and routine operation of QC laboratories providing product release and stability testing using methods developed and transferred from internal and external sources.
Responsibilities:
- Responsible for providing technical and strategic direction for the QC Laboratories that is aligned with the site goals and objectives. Prioritizes the deployment of laboratory resources to support manufacturing and release of API and drug substance, optimizes the operation of the quality control laboratory in a biopharmaceutical manufacturing setting, including all related infrastructure, documentation, equipment qualification and analyst training.
- Manages all aspects of Quality Control (QC), in support of Abzena GMP projects, and in full compliance with established cGMP and Abzena requirements and develop and implements long-term analytical testing strategies and execution of Quality Control programs.
- Ensures raw material, in-process and product release testing occurs in support of timely batch release using suitably qualified, calibrated and maintained laboratory instrumentation by adequately trained staff.
- Ensures that stability programs for clients and Abzena’s proprietary product are maintained and monitored in compliance with ICH guidelines and that trends are identified and communicated in a timely fashion.
- Maintains the analytical method lifecycle including method verification, technical transfer from development to QC, qualification and validation, troubleshoots complex laboratory issues and demonstrates strong reasoning skills in support of ongoing laboratory investigations.
- Provides leadership through complex laboratory investigations, ensuring identification and thorough investigation of unexpected test results (OOT/OOS) and laboratory events; reviews and approves deviation reports, change controls and CAPA. Ensures appropriate use of GMP Quality Systems to monitor, report and ensure compliance with KPIs for the QC Laboratory.
- Operates at a consistent and exemplary level of efficiency, leads a high performing, motivated and well trained laboratory leadership team through effective use of performance management tools to produce high quality and accurate results are well documented with a customer driven focus.
- Identifies and prioritizes the need for strategic capital projects for the QC labs, provides QC support for proposals made for introduction of new products into Abzena.
- Performs other related duties as assigned.
General Responsibilities:
- Operates to the highest ethical and moral standards.
- Complies with Abzena's policies and procedures.
- Adheres to quality standards set by regulations and Abzena's policies, procedures and mission.
- Communicates effectively with supervisors, colleagues and subordinates.
- Ability to participate effectively as a team player in all aspects of Abzena business.
- Demonstrated administrative leadership with knowledge-based expertise in related areas that can be applied to meeting Abzena's strategic goals.
- Serves as a mentor and leads performance management initiatives for laboratory personnel.
- Maintains and demonstrates knowledge of the drug development process from development through commercial manufacturing including regulatory requirements and guidance.
Qualifications/Skills Required:
- BS degree 15 with years, MS degree with 13 years or PhD with experience post degree of 10 years in a relevant discipline, (e.g., chemistry, biochemistry, biological sciences, bioengineering, etc.).
- Extensive knowledge of chemical/biochemical and functional assays
- Knowledge of regulatory guidelines relating to method development and validation
- Experience in hiring and staffing a growing organization and mentoring high potential individuals
- Complex thinker with ability to articulate options for ambiguous situations and make decisions
- Knowledge and Experience in CMC regulatory strategy
- Demonstrated people leadership
- Preferred experience in client-based environment.
- Preferred knowledge in Comparability and Compatibility studies, Reference standard management.
- Knowledge and experience in cGMP, ICH guidelines, USP, EP compendia! methods a
- Ability to work well under pressure, multi-task, organize and excel in communication.
- Excellent oral and written communication skills.
- Ability to work both independently and collaboratively
Physical Requirements:
- Ability to stand for 1-2 hours at a time, sit for 2 to 3 hours at a time.
- Stand/walk during entire length of shift.
- Use arms, hands and fingers to handle, feel or reach.
- Visual abilities including near and far sight, color, peripheral vision, depth and ability to focus.
FLSA: Exempt
Great Benefits:
100% Employer Paid Health, Dental, and Vision Benefits
100% Employer Paid Basic Life & AD&D, Short-Term Disability, Employee Assistance Program
5% 401k Employer Contribution through Fidelity
23 Days of Paid Time Off, increasing to 28 days after 5 years of employees
Tuition Fee Reimbursement up to $5, 250 per year for degree, certification, development programs
Abzena is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.
This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, and training.
Salary : $5 - $0
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