Senior Associate Director, Bio PMO & 3PM Fremont

Boehringer Ingelheim Fremont , CA 94537

Posted 1 week ago

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! #LI-MS1 *I-SF1 PDN1

Description:

Senior Associate Director, Biopharmaceutical Product Management Operations & Third Party Management manages and steers product launch and life cycle activities of commercial biopharmaceutical products. Ensures compliant, reliable, and cost competitive supply of external services for BI Fremont.

Accountable for overall product ownership and integrated product management within the Biopharmaceutical Business Unit and represents the product to internal and external stakeholders. Develops product strategic objectives and implements those objectives across the site.

Strategizes and manages external manufacturing and QC testing network to ensure supply of services providing Make and Buy analysis, driving Key Performance Indicators and optimizing the network and Business Releationship. This role is accountable for management of the outsourcing portfolio and optimization of related budgets for BI Fremont.

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 and implement network strategy for the 3rd party portfolio at BIFI

  • Establishes, leads, and coordinates the 3rd Party Supply & Qualification Management Team (3PSQM).

  • Performs comprehensive, cross-functional 3rd party (3P) management activities for BI Fremont, covering all aspects such as needs identification, market screening, contracting, vendor qualification and set up, monitoring compliant delivery of services, and discontinuation.

  • Creates and monitors the 3PM business plan based on long-term forecast / budget process and executes associated strategies to support BI Fremont.

  • Leads and manages the make-or-buy decision process with the appropriate functions and committees.

  • Conducts the vendor selection and qualification process in close collaboration with other functions.

  • Leads contract negotiation in close collaboration with cross-functional team.

  • Manages the respective 3P throughout the entire contract life-cycle.

  • Plans and directs the risk assessment and mitigation activities throughout the outsourcing process.

  • Organizes training and roll-outs of 3PM processes in Biopharmaceutical Business Unit.

  • Aligns with the Bio matrix functions in the outsourcing teams and with other 3PM organizations in Operations or R&D M.

  • Develops commercial product strategy in collaboration with internal/external clients

  • Establishes, leads, and coordinates the Biopharmaceutical Product Team Operations (BioPTO).

  • Performs comprehensive, cross-functional product management of selected commercial biopharmaceuticals products, covering all aspects such as supply chain, manufacturing, product safety and quality, regulatory, sourcing & outsourcing, CMC change management, risk management, product costs and budget management, investments and cost-benefit analysis, and crisis management.

  • Develops and optimizes supply chain design and associated product cost roadmap.

  • Ensures alignment of supply chain strategy with contractual / regulatory / legal requirements.

  • Develops and aligns cross-functionally regulatory and supply strategy for product related changes to ensure sustained market supply.

  • Assesses product related risks and implements mitigation strategies as appropriate.

  • Designs, implements and continuously improves the processes, systems and roles and responsibilities connected with 3PM, within BI definitions and guidelines.

  • Assesses, identifies, and initiates potential improvements of product design, manufacturing process, and cost.

  • Leads preparation for engineering, process performance qualification, and commercial manufacturing campaigns.

  • Leads/manages cross-functional troubleshooting team to address CMC issues.

  • Leads/manages cross-functional team to address regulatory observations and post-marketing commitments.

  • Leads/manages mock run for launch readiness.

  • Leads/manages planning and execution of transport validation program.

  • Manages and controls the outsourcing forecasting process and budget.

  • Establishes and implements cost budgeting and controlling process per COGS roadmap and monitors annual product budget.

  • Follow all relevant department policies, procedures, SOP and other requirements during execution and act at all times within the BI standards/ethics policies. Strong understanding and appreciation for regulatory requirements and compliance standards under which the Fremont site is operating.

Requirements:

  • Bachelor's degree/Master's degree from an accredited institution in Business Administration, Engineering and/or Biopharmaceuticals.

  • Minimum of ten (10) years Biopharmaceutical Product Management Operations & Third Party Management experience with experience and product life cycle activities of commercial biopharmaceutical products.

  • Minimum of six (6) years' experience in a people leadership role

  • One-plus (1 ) years of international exposure in daily business (>50% of international business/customers/staff) required.

  • Demonstrated ability to think strategically

  • Multi-disciplinary pharma industry experience in international environment.

  • Product launch and outsourcing selection and management experience is required.

  • Experience managing strategic and tactical/operational projects.

  • Broad pharma technical and business knowledge.

  • Strong knowledge of pharma end-to-end supply chain processes.

  • Able to screen, negotiate with, contract, and manage third party service providers.

  • Strong knowledge of pharma regulations, GMP, and business processes.

  • Excellent analytical, strategic and innovative thinking ability and strong business judgment.

  • Possesses planning and organizational skills. Able to professionally present to steering committees and key stakeholders.

  • Able to illustrate complex issues and evaluate them critically to navigate a goal-orientated decision process.

  • Working experience in continuous process improvement preferred

  • Excels in leading cross-functional teams including integration and management of stakeholders from international and matrixed structures.

  • Proven ability to engage, motivate, and develop cross-functional teams and the workforce.

  • Experience in multicultural environments.

  • Able to build trusting relationships and credibility with internal and external partners/customers.

  • Excellent communication skills with the ability to build rapport with management and employees and contribute to all aspects of the organization.

  • Strong analytical thinking, a broad and deep technical and business knowledge and with proven ability to engage, motivate, and develop cross-functional teams.

  • Incumbent should have ability to build strong trusting relationships and build credibility quickly with the colleagues, stakeholders, teams and workforce.

  • Expertise in Product Management Operations, Third Party Management, product launch and life cycle activities of commercial biopharmaceutical products.

  • Respect different cultures and diversity.

  • Extensive knowledge about business/functional strategies, processes, and organizational structures within Biopharmaceuticals & Operations including steering committees and decision-making processes.

  • Solution- and customer-focused.

  • Strong team player.

  • Conflict resolution skills.

  • Project management skills.

  • Change management skills.

  • Financial savvy.

  • Compliance & Regulatory savvy.

  • Assertive and persistent.

  • Able to manage a number of work streams simultaneously.

  • Willing to travel.

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, 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.

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Senior Associate Director, Bio PMO & 3PM Fremont

Boehringer Ingelheim