We are Kelly Science and Clinical, the second largest scientific staffing firm in the U.S. serving 90% of Fortune 100 companies. We have partnered with a rapidly growing full-service pharmaceutical contract manufacturing and development organization located in the Midwest, specializing in API Development, scale-up, and commercial manufacturing with an emphasis on process optimization.

Job Title: Process Development Manager -Pharmaceuticals

Overview

Company has a strong pharmaceutical and engineering heritage dating back to the founding of the company in 1969 and is now seekinga Process EngineeringManager to lead one of its cross-functional product development teams in this fast-paced and highly scientific organization.

Responsibilities may include (but are not limited to) the following:

• Responsible for managing the direction of the CMC strategy of new API product development programs with their cross-functional scientific team - (Chemistry Development, Analytical Development and Process Engineering) through design, optimization and into production.
• Directs and develops the process design and development plan with the team and ensures appropriate communication and partnership with the key stakeholders external to the work cell (e.g., production, EH&S, QC, and QA).
• The incumbent will play a key role in external communication with the customer in support of the Project Manager and is responsible for the collaborative development and performance of the team members.
• Ensures a high level of execution during development and manufacturing phases of the program, in alignment with the deliverables in the contract, and a high level of intrinsic value addition to the product.
• Leads the team through execution and supervision of the required process and analytical development and design to ensure a right-first-time control strategy is effectively created and implemented in production.
• Responsible for the scientific substance of projects, ensuring accountability of team members to functional standard work deliverables as well as their integration with other development functions.
• Embraces and develops a culture of innovation for the purpose of adding value to the customer's program.
• Serve as primary contact for customers and auditors concerning the scientific aspects of projects.
• Attracts, develops, and retains a high performing team to meet the current and evolving needs of the business through effective selection, training, and development, coaching and mentoring, and performance management.
• Ensures timely completion and compliance with cGMP and all other relevant company training requirements.

Required Education and Experience:

• Legally authorized to work in the job posting Country.
• 5-7 years of related experience required; 12+ years preferred
• Bachelor's Degree (Chemistry, Pharmaceutical Sciences, Engineering, or related) required. Master's or Doctorate Degree preferred.
• Functional knowledge of CMC project management, process and analytical chemistry, GMP and EHS guidelines.
• Ability to coach, mentor, and develop other employees.
• Drives timely completion of training for employees to meet regulatory requirements.
• Capable of leading cross-functional project teams.
• Ability to independently judge the scientific aspects of the chemistry, analytical, and process development plans. Support solving problems in projects and be able to prepare and lead project work plans.
• Previous Pharmaceutical experience required; prior CDMO experience preferred.

Our client offers a generous compensation & benefits package including relocation assistance

"EOE, including Disability/Vets"

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Why Kelly?

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About Kelly

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.