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Associate Director, QC Release and Stability

Company: Celgene
Location: Ayer
Posted on: June 25, 2022

Job Description:

At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science. In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.Bristol-Myers Squibb in Devens, MA is looking for a remarkable Associate Director, QC Release and Stability to join our phenomenal Quality Biologics team! As our Associate Director, QC Release and Stability, you will be responsible for running the Devens Biologics QC Release and Stability function.This QC organization performs all internal testing for release of commercial and clinical products manufactured at Devens.Additionally, the organization performs all drug substance and drug product stability testing for all of BMS' commercial biologic products. In that role, the AD of QC R accommodates strategies created at multiple drug substance and drug product manufacturing sites, and closely coordinates planning with the Global Stability organization. The AD will pro-actively ensure all QC activities are performed in accordance with regulatory and company standards, guidance, and procedures, and meet the requirements of the US and international regulatory agencies.Role Responsibilities:Own the operation of QC analytical laboratories supporting all BMS commercial DS and DP stability testing and all internal DS release testing for molecules manufactured in the LSCC and SUF facilities in Devens.Lead the analytical transfer required for new clinical or commercial molecules transferred into the SUF or LSCC.Lead the analytical transfer of stability testing methods as required for all BMS biologics drug substances or drug products. Transfers may be driven by method changes, new molecule introductions, or insourcing of existing methods from external labs.Rapidly respond to OOS and OOT results to support completion of timely and robust investigations.Actively engage in market actions and health authority notifications that result from OOS stability results. Provide technical support for all QC laboratory investigations.Develop and enhance the quality system to promote, facilitate and assure compliance with all regulatory and BMS standards.Maintain an inspection-ready laboratory at all times.Proactively improve systems to ensure data integrity, compliance with procedures, improve training, and enhance safety in the laboratory environment.Formulate strategies for and answer agency questions, observations, etc.Ensure that stability studies performed at the site are performed according to approved protocols and procedures.Ensure an effective process is in place for reserve sample collection and storage.Complete Annual Product Quality Review Report elements as established in products/systems schedule.Lead efforts to ensure the QC R group operates in compliance with company policies and directives, and evolving Health Authority regulations and expectations.Develop and advance action plans to achieve targets and drive performance. Own the QC release testing turn-around-time metrics and the stability testing timeliness metrics.Take action to address any deficiencies in delivery measures.Lead and foster an environment of continuous improvement.People Management and Strategic Leadership:Together with the Global Stability and Network Quality Control organizations, develop short- and long-term plans for stability testing volume.Accommodate corporate strategies for business continuity in DS and DP manufacture that trigger stability testing. Propose, obtain approval for, and lead implementation of staff, equipment, and facility changes necessary to accommodate the global stability testing strategy.Lead a large group of BMS employees and contractors through multiple subordinate group layers (Individual Contributor, Manager, and Sr. Manager levels.).Create a positive group culture that excels in safety, and in the BMS values: Passion, Integrity, Accountability, Urgency, Inclusion, and Innovation.Inspire transformative thinking and motivate employees to deliver benchmark performance.Assure robust succession plans for critical positions; actively support and develop talent.Lead the hiring, coaching and development of staff.Create development plans for the team, and succession plans for key roles within the QC R structure.Build and foster strong relationships within the biologics quality and global quality network to drive compliance, strengthen quality systems and support company objectives.Collaborate with other relevant sites within the network on technical issues and a shared quality approach.Manage Finance:Model resources and justify headcount and expenditures as part of regular budget setting and updating cycles.Ensure adequate resources exist for QC R Operations, including budget for staff, facilities, and equipment. Operate within the Devens Biologics Quality budget.Review and approve capital and expense expenditure.Role Competencies:In addition to the BMS values of Integrity, Innovation, Urgency, Passion, Inclusion, and Accountability, the job holder should exhibit:Experience in building and growing an organization, and ability to lead and motivate people.Ability to manage change effectively.Knowledge of biotech bulk and finished product manufacturing as well as analytical testing.Be very familiar with US and EU cGMP regulations and guidance.Experience with direct FDA, EMA, and Global HA interactions including face-to-face interactions and/or regulatory filings.Demonstrated leadership skills and outstanding interpersonal, communication and motivation skills.Strong interpersonal and communication skill set to effectively manage a diverse population of scientists across multiple scientific disciplines.Ability to embrace collaboration with partners, customers, and team members, operate with integrity, as well as seek and participate in the continuous improvement of systems and culture.Ability to build relationships cross functionally and influence internally/externally as appropriate.Role Qualifications:Minimum Bachelor's Degree, preferably Master's in biological science or related field.At least 10 years' experience in biopharmaceutical technical operation areas with minimum of 6 years of increasing management responsibility.In depth knowledge of analytical biochemistry quality control procedures, and the application and interpretation of GMP concepts and compendia requirements (e.g., USP, CFR) to daily laboratory operations.Knowledge of laboratory equipment, instrumentation, and techniques including, but not limited to, microbiology, cell and immunological biochemistry, separation sciences, spectroscopy, and physical analyses.Must have demonstrated ability to plan, implement, and achieve significant, complex goals and objectives. Demonstrated ability to work with and manage people in a complex, changing environment to deliver value added results to the organization.Strong background and demonstrated effectiveness in quality assurance and regulatory compliance of commercial biologics in a Globally regulated environment.Demonstrated leadership skills and outstanding interpersonal, communication and motivation skills.Ability to lead and motivate people.Ability to network globally within BMS and externally to stay current with latest requirements/trends/initiatives.BMS ValuesRefer to https://www.bms.com/about-us/our-company/our-mission.html for more information about the BMS Values.BMSBL, BMSBLDMA, VETERANAround the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation.Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment.This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Keywords: Celgene, Nashua , Associate Director, QC Release and Stability, Executive , Ayer, New Hampshire

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