Associate Director, Werum MES

Company: Boehringer Ingelheim
Location: Fremont
Posted on: July 18, 2021

Job Description:

Description:

Boehringer Ingelheim Fremont is the rapidly growing US arm of Boehringer Ingelheim’s Biologics Business Unit. We are a fully integrated biologics operation with over 500 scientist and specialists, covering cutting edge early- to late stage CMC development, clinical and commercial drug substance and drug product manufacturing, medical device assembly for combination products and packaging operations.  

We are continuing our rapid growth, investing over  $200m into the expansion of our capacity and capabilities, and creating approximately 200 new jobs. 

Driving this growth is an exciting pipeline of multiple Boehringer Ingelheim novel biologic entities (NBEs) and biosimilars, as well as, a growing diverse portfolio of therapeutics we develop and manufacture for other leading pharma and biotech companies. This includes multiple commercial product launches planned over the next couple of  years, for which we can tap into Boehringer Ingelheim’s unique experience of having brought 30+ biologics to market globally.

Leveraging our diverse talent pool, we are also driving technology and innovation globally, through major investment and collaborations into next generation manufacturing platforms and technologies, which may change how biologics will be made in the future.

Whether we work on our own products, help partners to bring their products to market or innovate new technologies and approaches - Everything we do, we do to help patients! 

Description\:

This position is responsible for leading all aspects of the BioMES program at BIFI.   Role is responsible for ensuring timely creation of electronic batch records within a highly complicated electronic system (BioMES) for manufacturing operations.  The position is also responsible to oversee BioMES system health at Fremont, which includes influencing local, national and global teams to standardize business processes and procedures,  to drive global integration projects (DeltaV, PI, LIMS, Stand Alone Equipment) and be accountable for local integration of these systems into new and existing batch records.  This role oversees all local administrative and maintenance functions of BioMES and ensures system upgrades are performed in a consistent, effective and GMP way to minimize interruptions to production operations.

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\:

• Directs and Manages BioMes Staff and site team to meet the needs for the system, the requirements of the production schedule and goals of the global BioMES team.  Proactively identifies and manages quality and compliance related actions for the BioMES system and ensures corrective actions are implemented.  Modifies plans and procedures to suit business demands.
• Plans and manages system integration activities in addition to BioMES system upgrades activities, ensuring site and global team project plans are comprehensive and realistic.   Develops expertise on new functionality and evaluates existing business processes for adjustment to meet short and long term goals for the site.  Leads integration teams and coordinates with local IT and EMS staff.
• Monitors and maintains BioMES system locally, including process performance and production results.   Identifies areas for improvement through continuous improvement methodologies and data driven decision making.   Accountable for local problem (trouble ticket) resolution including direct engagement with global teams and Werum.  Responsible for budgets and hiring within department.
• Represents Fremont site as the BioMES head at local, national and global levels.  Collaborates within department, cross-functionally and globally to develop and meet system objectives.   Gains alignment on local issues and day to day needs and garners support from the global functions.

Requirements\:

• Requires a Bachelors degree from an accredited institution, preferably in a science, IT or engineering related field, plus ten (10) years of experience in a cGMP pharmaceutical manufacturing environment with positions of progressive responsibility with a minimum of five (5) years of experience managing/directing people in a GMP environment or clean room assembly environment.
• Experience in critical decision making, working independently with very little supervision, champions problem resolution, knows when to escalate to upper management, and provides compliant and smart solutions for complex manufacturing issues.  
• Must have experience in managing diverse teams. 
• Must have experience in managing change in both projects and progressively developing staff.  
• Requires an understanding of basic biopharmaceutical manufacturing, specifically with creation and management of batch records.  
• Requires previous experience with Werum PASX. 
• Requires technical experience such that corrective actions resulting from procedural deviations or change controls are effective and that changes are made in accordance with CGMP. 
• Must be able to discuss and defend BioMES and Batch Records in a regulatory setting. 
• Requires prior demonstrated managerial competencies and very strong interpersonal skills. 
• Demonstrates knowledge in manufacturing principles relating to Werum PASX MES and ERP systems.  
• Requires intermediate understanding of biopharmaceutical manufacturing, resource planning, performance management and coaching concepts.

Eligibility Requirements\:

• 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 is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment, which benefits our employees, patients and communities. All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.

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Keywords: Boehringer Ingelheim, Fremont , Associate Director, Werum MES, Other , Fremont, California