Boehringer Ingelheim Hiring For Modeler Manager, Werum MES at Fremont, CA Full Time

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:

The position will be responsible for managing a team of individual contributors who create and maintain both paper and electronic batch production records in a fast paced, multi-product clinical and commercial manufacturing facility. The position will be accountable to ensure all deadlines are met to ensure high quality batch records are available for continued production. The manager needs to analyze, define and harmonize working standards, drive, coach and implement a continuous process improvement mindset to meet effectiveness targets, must include assimilating standalone systems (Equipment, PI, DeltaV, LIMS, etc) into electronic batch records, and drive the rapid conversion from paper records to electronic records. The position will support the operations teams to ensure manufacturing goals are met, while also monitoring work execution and team performance.

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 leads a team of BioMES Modelers and Technical Writers. Coordinates and plans all required work to assemble a quality batch record as a paper record or electronic record. Makes recommendations for appropriate staffing and balancing resource demands between different teams to meet the department goals in terms of quality, productivity and efficiency under cGMP conditions. Coordinates all schedules with Production Coordinators, Production schedulers and other stakeholders. Plans ahead and anticipates necessary adaptations to scheduling, staff allocation and organization to meet stretch manufacturing goals.
• Analyzes the resource demands for his/her operations and develops a skill profile for his/her organization. Ensures that positions are filled rapidly and the team members are developed appropriately through performance and talent management, succession planning and coaching. Further, the position will be responsible for identifying and critical gaps in staff training and mitigating gaps. Establish a development strategy for all manufacturing staff to ensure that the talents of the staff members are developed and talents are retained for the site/BI. The position ensures the right amount of cross training to allow flexible allocation of resources.
• Collaborates within department and cross-functionally to meet set objectives and lives a culture of collaboration. Represents BioMES on cross functional teams and initiates cross functional process improvements. Participates in cross-functional and global projects to align processes on a higher level. Facilitates to gain alignment between different functions on batch record issues and needs.
• Leads and facilitates project execution with involvement in multiple major projects simultaneously, strong understanding of requirements for maintaining GMP validated systems. Working knowledge of change control and CAPA processes and is accountable for following quality systems requirements.

Requirements:

• Requires a Bachelors degree from an accredited institution, preferably in a science or engineering related field, plus five (5) years of experience in a cGMP pharmaceutical manufacturing environment with positions of progressive responsibility with a minimum of three (3) years of experience managing/directing people in a GMP environment or clean room assembly environment
• In lieu of a Bachelor’s degree, will consider an Associate’s degree from an accredited institution, preferably in a science or engineering related field, with a minimum of eight (8) years of experience in a GMP environment or clean room assembly environment and with a minimum of three (3) years of experience managing/directing people in a GMP environment or clean room assembly environment
• In lieu of a Bachelor’s or Associate’s degree, will consider a High school diploma/GED plus ten (10) years of experience in a GMP environment or clean room assembly environment and with a minimum of three (3) years of experience managing/directing people in a GMP environment or clean room assembly environment.
• Position has moderate to high impact to manufacturing organization.
• Involves short to mid-term detailed planning as well as day-to-day tactical decision making with potential high cross functional impact.
• High degree of independence required for staff performance management and resource assessments.
• Requires intermediate understanding of biopharmaceutical manufacturing, resource planning, performance management and coaching concepts.
• Requires prior demonstrated managerial competencies and very strong interpersonal skills.
• Demonstrates knowledge in manufacturing principles relating to Werum PASX MES and ERP systems.
• Experience interviewing, hiring, training, developing supervising, coaching, motivating, developing and disciplining leadership staff is required.
• Must be able to motivate and mobilize staff
• Must be able to implement challenging goals and to develop a picture of the future state.
• Ability to read, develop, and understand procedures and other controlled documents
• Must have excellent written and verbal communication skills.
• Must have well-developed interpersonal skills with the ability to establish highly functional relationships with diverse personalities both within and outside the manufacturing.

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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