This Job Profile encompasses the roles of both the AD Cell Culture and the role of AD Purification skills, knowledge, abilities, education for manufacturing operations.
Both roles are responsible for ensuring compliance of the Manufacturing Processes in accordance with cGMP regulations within their area of expertise. They are also responsible to implement, maintain and monitor all quality processes necessary for that assurance.
The AD of Cell Culture is responsible for the areas of Cell Banking, Cell Inoculum, 100L through harvest which includes the 100L seed bioreactor, 400L seed bioreactor, 2K seed, 12K production bioreactor, centrifugation, and harvest operations. The AD of Purification is responsible for processes including chromatography, viral inactivation/filtration, tangential flow filtration, formulation, bulk filtration, and freezing operations.
Both the AD of Cell Culture Operations & the AD Purification leads and provides direction for a multi-tiered drug substance manufacturing team consisting of about 40 people. Both positions are responsible for the success of BI products (Biosimilars and NBEs- New Biological Entities) as well as CMB (contract manufacturing business) drug substance in the Fremont multi-product facility.
Both the AD of Cell Culture Operations & the AD of Purification provides technical expertise on standards and processes, creates a work environment that is collaborative and has a continuous improvement mindset. They both define and implement working standards, determines feasibility with production planning targets, provides input on the manufacturing strategy, and provides input on resource planning to achieve manufacturing and site strategy and goals.
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 several 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 the work of the Cell Culture or Purification group(s) to meet productivity, and efficiency goals to achieve operation and quality goals and objectives.
- Provides technical leadership in manufacturing operations, corrective and preventative actions, deviations and change controls as necessary to ensure departmental objectives and strategy is met.
- Establishes department vision and mission statements.
- Accountable for effectively leading, driving and managing change in the multi-tiered manufacturing team which consists of about 40 people.
- Manages a group of supervisors who manage operational staff.
- Analyzes the resource demands for the Purification group(s) and develops a skill profile for his/her organization(s).
- Ensures that positions are filled accordingly, and the team members are developed appropriately through performance and talent management, succession planning and coaching.
- Responsible for identifying and mitigating gaps in staff training and establishing 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.
- Ensures the right amount of cross-training to enable flexible allocation of resources.
- Plans, anticipates challenges, allocates staff to ensure the organization meets manufacturing objectives.
- Proposes and executes process and procedural changes to improve process performance, robustness, productivity, and efficiency.
- Applies metrics to departmental mission to drive continuous improvement.
- Ensures the Purification / Cell Culture groups continuously strive to improve standards.
- Defines compliance and safety goals for the multi-tiered organization.
- Develops standards for the state of the facility in floor organization and ensures subordinate leaders implement those standards in a consistent way.
- Accountable for developing solutions to improve safety and compliance topics.
- Ensures that a continuous process improvement culture is established within the leadership team and therefore within the organization under his/her direct control.
- Provides oversight for the development of project budgets and monitors expenditures.
- Optimizes allocated departmental resources.
- Works with clients, suppliers, contracted organizations, and other BI sites as necessary to achieve goals.
- Establishes and measures Key Performance Indicators relative to team performance relative to safety, quality, productivity, and improvement topics implemented.
- Compiles, organizes, and analyzes performance to continually seek improvement and directs team to establish solutions to those improvement topics.
- Collaborates functionally and cross functionally to implement Manufacturing strategy and objectives. Performs both independently and in team settings.
- Works closely with department Director to set and implement goals.
- Serves as leader for new initiatives relating to Cell Culture or Purification.
- Removes barriers to successful implementation and works to resolve them.
- Leads team to prepare Purification for audits and regulatory inspections.
- Leadership includes preparing managers and staff to defend aspects of drug substance operations as well as perform housekeeping walk throughs directly in advance of audits, role play, tour practice sessions, knowledge expectations and review.
- Provides strategic consultation to managers and staff to prepare for difficult topics.
- Ensures compliance of manufacturing processes and systems as well as department activities with national and international cGMP (e.g., FDA, EMA) and Company Policies, Procedures, Goals and Objectives.
- Follows all relevant department policies, procedures, SOP and other requirements and act always within the BI standards/ethics policies.
- Participate in BI interactions with various governmental agencies/regulators and external auditors.
- Coordination and communication between multiple departments, including Process Science, Quality, Engineering, and other functional areas.
- Work is primarily directed at the site; however, may interact with colleagues at other USA and worldwide sites.
- Requires interface management with all functions in Fremont. Key functions are Manufacturing Systems and Compliance, Quality Assurance, Quality Compliance and Validation, Quality Control, Quality Systems, Supply Chain and E&T Maintenance, Instrumentation and Qualification at BI Fremont and for defined projects globally.
- Participates in BI interactions with various governmental agencies/ regulators and external auditors.
- Can work with outside CMO clients and suppliers as needed and provide a competent and professional image for BI.
- Requires a Bachelor’s degree, preferably in a science or engineering related field with 8 years of cGMP pharmaceutical experience in positions of progressive responsibility plus a minimum of 5 years’ 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, preferably in a science or engineering related field with a minimum of 12 years’ experience including minimum of 5 years proven record of 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 +13 years’ experience including minimum of 5 years proven record of managing/directing people in a GMP environment or clean room assembly environment.
- Strong understanding and appreciation for regulatory requirements and compliance standards under which the Fremont site is operating.
- Creates and communicates a vision of the future.
- Sets the business priorities, factoring in the internal and external context.
- Instills passion to succeed, to win in the market.
- Challenges conventional thinking and established practices.
- Proactively anticipates future needs and relentlessly spots new opportunities that add value.
- Promotes learning from success and failure.
Lead and Manage Change\:
- Promotes understanding for change and continuous improvement.
- Provides options and ways to overcome resistance and uncertainty.
- Encourages diversity of people and perspectives.
- Treats others with respect and understanding.
- Builds engagement through collaboration and knowledge sharing.
- Coaches and develops people to recognize areas for improvement and build upon their strengths.
- Sets high standards and drives results by giving and seeking feedback.
- Uses sound judgment and makes timely decisions.
- Realizes results, despite challenging conditions.
Technical expertise in Manufacturing Operations\:
- Cell Culture Operations.
- Regulatory Requirements in Biopharmaceutical Operations.
- Requires interpersonal, investigative and implementation skills.
- Ability to think strategically and has strong business judgment.
- Demonstrated influencing, relationship building, and effective facilitation.
- Excellent communication skills with the ability to Influence Cross functionally. Ability to handle multi tasks and provide the leadership and strategy to a team.
- Expertise in biopharmaceutical manufacturing practices, quality processes, compliance management and the data trending principles.
- Experience leading leaders.
- Experience in managing continuous improvement initiatives.
- Experience in strategic planning for continuous improvement.
- Indicate whether knowledge of the industry, sector, competitors, and products is required and provide details of whether negotiation skills are necessary in this role (whether internal or external).
- 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.
- This position will require individuals to be fully vaccinated against COVID-19 or have an approved medical or religious accommodation. Click here for more information on the vaccine mandate and COVID-19.
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, including natural hairstyles, hair texture and protective hairstyles; 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.