Process Development Manager
About The Position
It’s not what we make, it’s what we make possible. And the possibilities at Lifecore are endless! This full-time position offers incredible benefits and a company culture focused on development and growth, including strong opportunities for learning, advancement, and career progression. Lifecore has a Process Development Manager opportunity based onsite in Chaska, Minnesota. The Process Development Manager leads a team of Process Development Engineers supporting early to late-stage clinical programs. This role oversees the development, optimization, and scale-up of drug product and medical device manufacturing processes from early-stage development through commercialization. As a key technical leader, this position partners closely with cross-functional partners to ensure processes are scientifically sound, robust, scalable, and compliant with regulatory and quality standards.
Requirements
- 8+ years of progressive process development experience within a medical device, (bio)pharmaceutical, or other highly regulated manufacturing environment
- Prior leadership experience, including direct supervision of technical teams and project leadership
- Proven success leading development and scale-up programs in a regulated environment
- In-depth understanding of drug product formulation unit operations
- Strong knowledge of formulation development, scale-up, and compatibility with materials of construction
- Strong understanding of cGMP, ICH guidelines, and regulatory expectations
- Proven capability in planning and leading technical development projects
- Strong technical writing skills with experience authoring protocols and reports
- Strong critical thinking, root-cause analysis, and problem-solving skills
- Effective team facilitation, project management, and communication skills
- Bachelor’s degree required; Chemical Engineering, Pharmaceutical Sciences, or related field preferred
Nice To Haves
- Master’s degree or PhD preferred
- Experience with sterile injectables and/or biologics
- Familiarity with technology transfer documentation and product lifecycle management
Responsibilities
- Lead, mentor, and directly supervise process development engineers, fostering a high-performing, accountable, and collaborative team
- Establish clear roles, responsibilities, and expectations while holding self and others accountable for results
- Act as a hands-on leader, maintaining a strong presence “on the floor” to support execution and troubleshoot issues
- Recruit, train, coach, and develop team members; effectively address performance concerns
- Share and communicate a clear technical and operational vision aligned with business objectives
- Manage timelines, resources, and budgets across multiple process development projects
- Lead development, optimization, and scale-up of drug product and medical device manufacturing processes
- Apply Quality by Design (QbD) principles, risk assessments, and statistical tools to ensure process robustness
- Evaluate technical feasibility and suitability of new projects and incoming opportunities
- Identify, investigate, troubleshoot, and resolve complex technical and manufacturing issues
- Collaborate with internal stakeholders to support process scale-up and technical transfer into GMP manufacturing
- Develop and review tech transfer documentation, protocols, risk assessments, and final reports
Benefits
- Opportunities to learn and grow with a well-respected company
- Competitive compensation with annual reviews and a company-wide incentive bonus
- Benefits that start the first of the month after you join Lifecore as a full-time employee:
- 3 medical insurance plans to fit your needs and budget including an HSA Plan with a generous company contribution.
- Low cost dental and vision insurance
- Short term disability, long term disability and life insurance all 100% company paid
- 3 weeks PTO in the first year (increases to 4 weeks after just 2 years!)
- 9 paid company holidays plus 2 personal holidays
- Paid family leave
- Tuition reimbursement
- 401k plan with company matching contribution
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What This Job Offers
Job Type
Full-time
Career Level
Manager
Number of Employees
101-250 employees
