Mid-level industry position
The Carlsbad Gene Therapy Viral Vector Manufacturing is a contract manufacturing site that produces drug substance and drug products for gene therapy and oncology applications. We are seeking a qualified Biochemistry Manager who will be responsible for leading all aspects of biological and chemical assay activities to support client processes and manufacturing activities, ensuring compliance with the established SOPs, cGMP, and all regulatory agencies. He/she will need to provide leadership at all levels of the organization as well as communicate and embody the company vision and values.
This role will be overseeing Biology and Chemistry team performing method feasibility, method qualification/validation, raw material qualification, raw material testing, stability testing, in-process testing associated with the production of our products. The candidate must possess a deep understanding of the pharmaceutical development processes from pre-clinical development through the life-cycle management. The selected candidate will be fully engaged with cross-functional teams seeking to develop new chemical and biological assays to support and enhance company’s assay platforms.
As the Biochemistry Manager you will maintain and drive comprehensive quality metrics associated with testing related to our contract manufacturing business, including developing and driving appropriate Key Performance Indicators (KPIs) managing timelines and working with various stakeholders to successfully deliver client deliverables, while helping to maintain our production environment in a state of readiness. You will effectively lead, track and trend the Biology and Raw Material Program at the Carlsbad site as well as initiate and drive change for the site while interfacing with internal and external clients and develop a best-in-class Biology and Chemistry team.
This role will also be the primary scientific resource and Subject Matter Expert (SME) for the Biology and Chemistry team for the site. You will be the primary expert in providing technical advice and support for internal and external interactions during client and regulatory audits/inspections, meetings, and teleconferences. The role will entail operating in a fast-paced, highly dynamic environment with key company work partnerships, including both internal and external stakeholders.
ESSENTIAL JOB FUNCTIONS
- Lead, manage and develop the Biology and Chemistry team to support the daily operations of the Manufacturing and Process Development group.
- Ensure QC labs compliance with ISO, FDA, cGMP, EMA and Millipore requirements.
- Develop and report on Quality metrics for the Biology and Chemistry testing (raw material and in-process testing). Ensure that those metrics are met, that lab performance is continually improving, and that metrics are communicated periodically throughout the site.
- Perform water testing (pH, TOC, Conductivity, Endotoxin and Bioburden), HPLC, ID testing, cell culture and PCR testing, as well as analysis and interpretation of data generated by the team.
- Prepare/ review protocols and final reports as needed.
- Support/ participate in new product transfers into Manufacturing. Provide strong technical leadership, expertise and specialized knowledge in test method feasibility/qualification, component qualification, raw material sampling plans and adherence to the Product Development Process (PDP).
- Drive implementation of new services. Keep abreast of potential new technologies to enable the design of new assay and test methods.
- Liaise with Quality Assurance and appropriate cross-functional departmental areas to leverage knowledge and experience not being available in house.
- Create/Revise SOPs, laboratory records and other related documentation as needed.
- Maintain fluency with evolving global regulatory requirements and industry standards for analytical testing and characterization of biological products.
- Responsible for coaching employees, determining employee’s responsibilities, performance review, and development plans.
- Coach/ train employees on developing, improving and enhancing day to day laboratory techniques.
- Build up the company by recruiting, interviewing, hiring, training, and mentoring new talent.
- Promote a culture of continuous improvement within Method Development and Quality Control; act as champion on initiatives to drive improvement in quality and client services.
- Comply with company EH&S requirements. Promote a safety-first culture.
- 5+ years of working experience in Quality Control.
- Previous leadership/supervisory experience.
- Strong foundation in Lean Manufacturing and Continuous Improvement.
- Working knowledge of validations, calibration systems, process design, design of experiment, instrumentation, automation, and digitization/paperless system.
- Operational knowledge of the regulation (cGMP, ISO, EMA) and directives, and liability for non-compliance.
- MA/MS or PhD.
- Understanding and knowledge of governmental regulatory guidelines relating to the manufacturing of biologics and pharmaceuticals as well as compendial methods.
- Ability to work successfully, strategically and tactically in a fast-paced, multi-disciplinary environment with potential for rapidly changing priorities.
- Proven ability to establish direction and obtain commitment to ensure that projects are completed by deadlines and streamlining processes to maximize productivity.
- Excellent communication, organization, analytical and technical writing skills.
- Possess understanding of group dynamics and have the ability to effectively influence group decision-making process. Ability to make thoughtful, integrated, timely and meaningful recommendations and/ decisions and take corresponding actions.
- Strong oral and written communication skills, discretion and confidentiality required to interface with sensitive employee relations.
- Ability to analyze past and current data/trends and recommend objectives/directives to improve productivity and increase efficiency.
- Thorough knowledge of method development, qualification and validation and method transfer principals.
Job Requisition ID: 188469 Working time model: full-time
US Disclosure The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.North America Disclosure The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.