The primary purpose of the Associate Director/Senior Associate Director MSAT Upstream is to provide leadership and to manage the Upstream (US) Manufacturing Science and Technology (MSAT) group. Leadership includes directing projects and personnel, coaching and mentoring experienced staff, developing and driving initiates to increase efficiency and the robustness of manufacturing operations and promoting effective cross functional communications and collaborations. In addition to leadership the Associate Director (AD) / Senior Associate Director (Sr. AD) must provide technical and scientific expertise to all areas of responsibility of the US MSAT group. The position holder must be an effective representative of BIFI and BI in interactions with, regulators, vendors, collaborators, and all customers internal and external. The AD/Sr. AD must live the BI values and promote a positive work environment for his/her direct reports as well as others. The position is accountable for efficiently and accurately addressing process and facility capability questions regarding the US GMP manufacturing areas. Qualified candidate will be hired at the appropriate level (Associate Director or Senior Associate Director level) to commensurate with education and years of relevant experience.
The AD/Sr. AD ensures that scientific principles and practices are applied to all activities of the US MSAT group and that all conclusions reached and recommendations made are scientifically defensible and adhere to all Quality and Compliance standards. Corporate strategy and goals are translated into actionable deliverables by the AD/Sr. AD, who will ensure that deliverables are tracked, measured and the goals and objectives are met. The AD/Sr. AD creates proposals and directs the creation of proposals to improve operational efficiency. The AD/Sr. AD ensures that all proposals are thoroughly developed to maximize benefit and minimize risk and cost.
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
* Develop strategies, provides guidance and is accountable for ensuring that scale-down/scale-up and characterization of Upstream Manufacturing processes at BIFI are done in a robust, scientific manner leading to predictable process performance and a well characterized process.
* Provides guidance and is accountable for determining the root causes of process related deviations in the Upstream area in a timely and conclusive manner. This position leads comprehensive data analysis of process statistics, identifies process deviations, assesses product impact, prepares technical reports and proposes comprehensive process solutions and improvements.
* Participates in training and development opportunities in order to gain an understanding of standards of practice, process science and departmental policies. Provides comprehensive training and guidance to experienced scientists.
* Provides guidance and is accountable for rapidly producing accurate Initial Facility Fit assessments for the Upstream portion of the GMP Manufacturing facilities and communicates this information in a clear and concise manner to internal and external customers while showcasing BIFI and BI's strengths and capabilities to external customers.
* Proactively identifies and initiates executes process and procedural changes to improve business process performance, Upstream manufacturing process robustness, productivity, safety and efficiency. The position will generate unique and innovative contributions to the BIFI site to improve overall site performance and is accountable for evaluating impacts of proposed changes on product quality and regulatory.
Identifies and drives continuous improvement in innovation and technology and contributes to a stronger IP position for BI. This position will support establishing state-of-the-art technologies for manufacturing science as well as supporting facility, and production equipment modifications needed to maintain state-of-the-art production. Leads and drives cross functional collaborations to ensure changes are truly state-of-the-art, integrate well into BI systems and to ensure that best practices are shared.
* Initiates cross functional collaborations to align and recommend facility expansions/modifications to meet business needs. Develops strategies, provides guidance and is accountable for ensuring that designs for facility expansion and / or modification are optimized to support current and future Upstream process requirements and are reflective of opportunities created by proposed process improvements.
* At least Bachelor’s degree from an accredited institution with ten with (10+) years’ experience OR Master’s degree from an accredited institution with eight plus *(8+) years’ experience OR PhD from an accredited institution with six plus (6+) of relevant experience in Cell Culture.
* Six plus (6+) years’ experience leading employees, project and leaders.
* Thorough knowledge of biologics CMC, cGMP and upstream 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 and other biologics.
* Proven skills in building and maintaining productive with relationships organizational partners such as Manufacturing, Quality and Regulatory Affairs.
* Strong technical knowledge of Upstream manufacturing principles, techniques and equipment.
* Demonstrated ability to trouble shoot manufacturing processes, investigate atypical process events and develop valid process scale down models.
* Proven track record of developing and implementing efficient and robust manufacturing processes and technologies for monoclonal antibodies and complex biologics.
* Business Process Excellence, 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 management.
* 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.
* Accountable to answer process related questions of regulators. The position must have expert knowledge of upstream processes and related manufacturing equipment and facility attributes for the BIFI site. The position must interact with regulators in a manner consistent with BI training and guidance and the position must exemplify BI values in these interactions.
Desired Skills, Experience and Abilities:
* Experience/Expertise in a scientific discipline (chemical/biochemical engineering, biopharmaceuticals, biotechnology, molecular biology, biochemistry, cell biology)
* 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
Boehringer Ingelheim is a different kind of pharmaceutical company, a privately held company with the ability to have an innovative and long term view. Our focus is on scientific discoveries that improve patients' lives and we equate success as a pharmaceutical company with the steady introduction of truly innovative medicines. Boehringer Ingelheim is the largest privately held pharmaceutical corporation in the world and ranks among the world's 20 leading pharmaceutical corporations. At Boehringer Ingelheim, we are committed to delivering value through innovation. Employees are challenged to take initiative and achieve outstanding results. Ultimately, our culture and drive allows us to maintain one of the highest levels of excellence in our industry. Boehringer Ingelheim, including Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim USA, Boehringer Ingelheim Vetmedica Inc. and Boehringer Ingelheim Fremont, Inc. is an equal opportunity employer - Minority/Female/Protected Veteran/Person with a Disability
Boehringer Ingelheim is firmly committed to ensuring a safe, healthy, productive and efficient work environment for our employees, partners and customers. As part of that commitment, Boehringer Ingelheim conducts pre-employment verifications and drug screenings