Process Development Manager

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.

Technical & Team Leadership

• 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

Process Development & Technology Transfer

• 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

Required Education

• Bachelor’s degree required; Chemical Engineering, Pharmaceutical Sciences, or related field preferred
• Master’s degree or PhD preferred 

Required Experience

• 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
• Preferred: Experience with sterile injectables and/or biologics
• Preferred: Familiarity with technology transfer documentation and product lifecycle management

Required Technical & Leadership Competencies

• 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

Starting Salary: $150,000 - $175,000 annually with consideration for relevant experience

Lifecore offers a highly competitive total rewards package, including:

• 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

Meet Lifecore Biomedical, LLC:

Lifecore Biomedical, Inc. (Nasdaq: LFCR) is a fully integrated contract development and manufacturing organization (CDMO) that offers highly differentiated capabilities in the development, fill and finish of sterile injectable pharmaceutical products in syringes, vials, and cartridges, including complex formulations. As a leading manufacturer of premium, injectable-grade hyaluronic acid, Lifecore brings more than 40 years of expertise as a partner for global and emerging biopharmaceutical and biotechnology companies across multiple therapeutic categories.