Manager, Process R&D

Thermo Fisher Scientific•Florence, SC

12h•Onsite

About The Position

You will join the Process R&D department to support manufacturing of active pharmaceutical ingredients at the Florence, SC east site. Many of our products are already in the market serving patients. We work on a variety of projects for existing and new clients. At this position, you will manage a team of process chemists to support technology transfer, process development and manufacturing. We have a fast-paced working environment while keeping a good work-and-life balance. Drive all technical aspects of a project through completion by planning and executing synthetic activities ranging from pre-clinical to post-production campaigns. Monitor progress of pre-validation activities and write comprehensive reports. Lead strategic initiatives and solutions and oversee implementation. Lead meetings/teleconferences with clients. Lead a team over multiple projects; manage team's project timelines and deliverables; review group's financials. Engage in process technology transfer of projects. Direct resolution of problems related to API production. Liaise with internal scientific, analytical, and laboratory functional areas to meet project and team objectives. Perform all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices and Safety guidelines. Maintain the necessary compliance status required by company and facility standards.

Requirements

PhD in Chemistry or commensurate experience, PhD in Organic Chemistry preferred
9+ years of industrial experience
Process Chemistry experience in a GMP environment required.
Good project management skills.
Customer interaction experience required.
Clear and effective communication skills (both oral and written).
Supervisory experience required.
Process validation experience preferred.
Widely recognized as a SME.
Expert knowledge of scientific methodology and development as related to pharmaceutical development.
Thorough knowledge of Good Manufacturing Practices.
Strong proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint).
Superior critical and logical thinking skills with an ability to communicate ideas to employees and clients at multiple levels.
Effective written, interpersonal, and presentation skills, including managing technical discussions with internal and external clients.
Ability to work on and lead multiple projects simultaneously.
Ability to delegate work.
Ability to train and develop direct reports.
Ability to maintain and expand expert knowledge and to keep current with scientific literature and industry trends relating to process technologies.
Ability to develop technical solutions.
Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pound pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.

Nice To Haves

Process validation experience preferred.

Responsibilities

Drive all technical aspects of a project through completion by planning and executing synthetic activities ranging from pre-clinical to post-production campaigns.
Monitor progress of pre-validation activities and write comprehensive reports.
Lead strategic initiatives and solutions and oversee implementation.
Lead meetings/teleconferences with clients.
Lead a team over multiple projects; manage team's project timelines and deliverables; review group's financials.
Engage in process technology transfer of projects.
Direct resolution of problems related to API production.
Liaise with internal scientific, analytical, and laboratory functional areas to meet project and team objectives.
Perform all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices and Safety guidelines.
Maintain the necessary compliance status required by company and facility standards.