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27 days old

Chemistry, Manufacturing & Controls - (CMC)Manager - API

Kelly Services
Germantown, WI 53022
**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 seeking a Process Engineering Manager 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 customers 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

+ Bachelors Degree (Chemistry, Pharmaceutical Sciences, Engineering, or related) required. Masters 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**


**\#TJP2021_SPEC**


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**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 benefits ?). 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. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2021-09-20 Expires: 2021-11-04

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Chemistry, Manufacturing & Controls - (CMC)Manager - API

Kelly Services
Germantown, WI 53022

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