The primary purpose of this position is to lead and manage the Clinical Supply/Manufacturing Science & Technology department within Process Science. This position is responsible for efficient and timely delivery of high quality GMP biologic drug substance for human clinical trials and provides scientific, and technological and experimental supports for biopharmaceutical drug substance and drug product process transfers, launch and commercial supply. This position will oversee strategy of Clinical Supply, Purification and Cell Culture.
The position delivers results through effective leadership and management of a diverse team of scientists and engineers, and builds and maintains effective cross-functional partnerships with stakeholders. This position will direct, coach and mentor highly experienced staff/managers and matrix team members; develop and monitor resource plans, schedules, budgets and goals; translate strategy into objectives for the department; develop standards around which others operate; and be accountable for administration and results in the department. This position interfaces with internal and external clients, and deliver results to the highest professional standard to meet customer commitments. The incumbent is responsible for generating innovative and business driven ideas to improve processes and technologies, write proposals, support and/or manage external partnerships. Ensures that Department and hence Process Sciences Fremont becomes and remains a recognized center of excellence in biologics CMC in the biotech industry.
The person will ensure lean, efficient & reliable supply for tox and clinical studies, establishing and maintaining state-of-the-art manufacturing technologies and scale-down models by applying in-depth expertise of cell culture, purification and drug product technologies, quality systems and cGMPs, broad & deep scientific and engineering know-how, as well as, sound leadership and management skills.
As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.
Duties & Responsibilities
- Provides leadership to the department. Builds, develops and maintains group with cutting edge expertise and capabilities. Mentors, coaches and develops staff and supports capability and skill level improvement. Builds, maintains, operates and continuously improves drug substance and drug product manufacturing technologies for monoclonal antibodies & other biologics Fremont.
- Monitors and analyzes process performance of manufacturing processes in disposables and stainless steel facilities. Provides scientific and experimental supports for process validation and characterization, product launch, continuous process improvement, trouble shooting, facility fit, and deviation investigation and resolution for biologic drug substances and drug products.
- Ensures rapid and efficient transfer and implementation of cell culture and purification processes into the disposables facility for GMP clinical manufacturing. Ensures that team efficiently navigates site-wide and global quality systems. Pro-actively identifies obstacles and overcomes them, while ensuring compliance with cGMP and safety guidelines, quality policies, directives and procedures.
- Ensures efficient, lean & reliable execution and compliant documentation of cGMP manufacturing of drug substance for human clinical trials, with high quality and at low cost. Ensures efficient troubleshooting where needed utilizing sound analytical skills, independent thought and scientific/technical proficiency.
- Interfaces effectively with partner organizations both inside and outside of Process Sciences (Quality, Engineering, Manufacturing etc.), as well as, external partners and customers to ensure successfully process transfer, process validation, regulatory filings and timely delivery of GMP drug substance. Leads and fosters team approach. Ensures communication flow within team and to management, and properly escalates.
- Fosters an innovative environment and culture. Keeps abreast of industry best practices and technological advancements in biologics manufacturing science and technologies. Leads manufacturing technologies and innovations for continuous process and workflow improvements. Drives and/or supports innovative technology projects and ensures successful implementation of novel technologies in GMP drug substance and drug product manufacturing to further enhance Fremont's capabilities.
- Ensures optimal organizational structure for the department and establish flexible capabilities to support cell culture, protein purification, drug product manufacturing and operation functions of the department. Collaborates closely with other PS Directors and peers to rapidly adapt to the dynamic business environment and changing project portfolios. May lead and manage people and development teams in matrix organization. Provide on-the-job training, coaching and technical guidance to other team members.
- Completes all EHS related training and ensures work place safety
- Accountable for cleaning process development, namely for the development of cleaning procedures for bio manufacturing equipment. The focus is on cleaning recipes for product contacting surfaces and with emphasis on the physical and chemical aspects of the cleaning protocol. Collaborates with other key stakeholders such as PTPE, Quality, and E&T while developing cleaning procedures.
- Doctoral degree from an accredited institution plus six (6) years of experience OR Master’s degree from an accredited institution plus eight (8) years of experience OR Bachelor’s degree from an accredited institution plus ten (10) years of experience.
- Six plus (6 ) years’ experience leading employees, project and leaders.
- Thorough knowledge of biologics CMC, cGMP and manufacturing science and technology.
- Proven track record of building and leading small to large teams of highly qualified scientists and engineers in both development and GMP clinical manufacturing of monoclonal antibodies, complex glycoproteins and other biologics.
- Proven skills building and maintaining productive relationships with Manufacturing, Quality and Regulatory Affairs.
- Demonstrated ability to trouble shoot manufacturing processes, investigate atypical process events, develop valid process scale down models and deliver high quality GMP biopharmaceutical drug substance for early- to late-phase clinical trials, on time and on budget.
- Proven track record of developing and managing substantial budgets for continuous Manufacturing process improvement and GMP clinical operation.
- Proven track record of developing and implementing efficient and robust manufacturing processes and technologies for monoclonal antibodies and complex biologics.
- Thorough knowledge of clinical manufacturing workflow and manufacturing science and technologies.
- Proven skills building and maintaining productive relationships with organizational partners
- BPE, project management and goal setting.
- Ability to lead effectively in a highly matrixed organization.
- Maintain a continuous process improvement mind set and in depth understanding of transformations/change mgmt.
- Strong team leadership and staff coaching and development skills.
- Strong ability to influence in a team environment and collaborate with peers.
- Translate innovation goals into scientifically sound projects.
- Support and implement Process Science mission, vision and strategy and as representative at all interfaces.
Desired Skills, Experience and Abilities:
- Requires in-depth technical and leadership experience in drug substance and drug product manufacturing; building, qualification and successful operation of flexible GMP clinical supply facilities utilizing state-of-the-art disposables technology.
Must be legally authorized to work in the United States without restriction.
Must be willing to take a drug test and post-offer physical (if required)
Must be 18 years of age or older
Who We Are:
At Boehringer Ingelheim we create value through innovation with one clear goal: to improve the lives of patients. We develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family owned company we focus on long term performance. We are powered by 50.000 employees globally who nurture a diverse, collaborative and inclusive culture. Learning and development for all employees is key because your growth is our growth.
Want to learn more? Visit boehringer-ingelheim.com and join us in our effort to make more health.
Boehringer Ingelheim, including Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim USA, Boehringer Ingelheim Animal Health USA Inc., Boehringer Ingelheim Animal Health Puerto Rico LLC and Boehringer Ingelheim Fremont, Inc. is an equal opportunity and affirmative action employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; citizenship status, marital, domestic partnership or civil union status; gender, gender identity or expression; affectional or sexual orientation; pregnancy, childbirth or related medical condition; physical or psychiatric disability; veteran or military status; domestic violence victim status; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by applicable federal, state or local law.