A career with MilliporeSigma is an ongoing journey of discovery: our 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. MilliporeSigma is a business of Merck KGaA, Darmstadt, Germany.
Leadership of all Manufacturing activities and programs at the Carlsbad Viral Vector Manufacturing site.
Be responsible for ensuring the successful GMP manufacture and release of products, promoting a culture of quality and compliance, and achieving continuous improvement.
Be involved in managing a multi-product manufacturing department, the supervision of approximately 40 staff members, including manufacturing direct labor and the Process Engineering team responsible for production equipment.
The position reports to the Site Director and is a member of the site leadership team.
Who you are:
- Bachelor's degree required, in a science related field
- At least 5 years of managing a multi-product GMP manufacturing facility involving the complex scheduling and coordination of staff, materials and manufacturing operations
- Ability to drive continuous improvement, leveraging data and technology to impact quality, maintain innovative thinking habits and actively seeking to partner with Quality teams to ensure highest quality manufacturing and operational success
- In-depth knowledge of FDA, EMA, GMP & ICH regulatory requirements
- Knowledge of Quality Systems as they relate to GMP production operations and process optimization
- Capable of motivating others, creating a positive work climate where interdepartmental collaboration, coaching and performance feedback are continuous.
- Capable of clearly assigning objectives, clearing setting, measuring, & monitoring progress, marshaling resources and handling competing priorities
- Knowledgeable and compliant with all pertinent safety policies, rules and regulations. Adept at safety beset practices and acts in compliance with Environmental, Health & Safety regulations.
- Manage buffer preparation, GMP production, and fill/finish teams and activities
- Manage Process Engineering team which is responsible for maintaining all manufacturing equipment in a functioning and validated state.
- Identify and mitigate risks in manufacturing that could adversely impact project outcomes and timely delivery of critical treatments to patients
- Engage in internal process development activities related to technology transfer and scale-up
- Participate in the design, construction, and commissioning of expanded manufacturing facilities
- Partner with Failure Investigation group to report, investigate, and resolve deviations encountered during GMP production
- Ensure the structure and staffing of manufacturing department is adequate to meet site objectives
- Establish and maintain training requirements for manufacturing staff
- Develop, implement and improve GMP systems and procedures (equipment, SOPs, operational SOPs, Manufacturing Batch Records, etc.)
- Ensure equipment and facility are in a state of qualification to perform routine GMP manufacturing
- Develop the manufacturing budget and manage areas of responsibility within approved budget and contracted scope of work
- Create and track metrics demonstrating successful manufacturing operations
- Participate as the primary manufacturing representative for customer and regulatory audits
- Assist in the preparation of business development presentations, and occasionally assist with site tours and visits
- Provide responses to RFI & RFP inquiries from potential customers
- Attend conferences, and occasionally present operational related information
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
Curious? Apply and find more information at https://jobs.vibrantm.com
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.