Kelly Services Associate Director, Purification Development in Southborough, Massachusetts
Title : Associate Director, Purification Development
Location : Southborough, MA
Salary : 135-150k
About us :
We are a global contract development and manufacturing organization (CDMO). We provide full spectrum services for the production of biological products from microbial and mammalian cell culture processes. Our services include (1) cell line/strain development, (2) upstream, downstream and analytical development, (4) drug formulation development, and (5) GMP production.
Summary of Position :
The Associate Director of Purification Development will lead a team of purification scientists and associates to develop purification for biologics drug substances and support subsequent clinical and/or commercial GMP manufacturing. As a core member of the Biopharmaceutical Development management team, the director will be responsible for the strategic planning and growth of analytical development functions.
• Design and lead the development of primary recovery, chromatography, ultrafiltration/diafiltration, viral filtration/inactivation, and formulation for biologics drug substances.
• Manage process/technology transfer (externally from client or internally to Manufacturing) and provide manufacturing support and troubleshooting.
• Support IND/BLA CMC purification process document preparation.
• Direct purification innovation projects, new technology evaluation/ implementation, as well as conference presentation and journal publication.
• Contribute to department and corporate strategic planning and objectives setting.
• Mentor team members and manage department budget.
• Provide technical support to business and sales team and represent purification development functions in client meeting.
• Author SOPs, protocols and technical reports and ensure adherence to high technical standards and compliance with applicable regulatory guidelines.
• Maintain accurate experimental records and results in laboratory notebook and/or datasheet.
• B.S., M.S. or PhD in Chemical/Bio Engineering, Biochemistry or related discipline with in-depth knowledge and strong hands-on experience with biologic/protein purification in biopharmaceutical industry.
• Ph.D. with ?5 years or MS with ?8 years or BS with ?10 years of industry experience in downstream process development, characterization, and qualification for biologics.
• Strong hands on experience with AKTA purification systems (purifier, explorer) is required, ability for AKTA equipment trouble shooting is highly preferred.
• Experience with ion exchange, hydrophobic, mixed mode and affinity chromatography with AKTA purification systems.
• Able to analyze complex downstream process related problems, develop strategic initiatives and execute technical programs, and make recommendations to executive management.
• Proficiency with protein assay, gel electrophoresis, HPLC, ELISA is preferred
• Knowledge and hands-on experience of microbial fermentation and mammalian cell culture is a plus
• Ability to work in a fast pace environment, manage priorities, and maintain timelines for multiple projects is required.
• Strong knowledge in PAT technologies, GMP / ICH guidelines and CMC experience.
• Advanced cross-functional communication, written and presentation skills.
• Effective organizational and staff management skills.
• Proficient in statistical design of experiment and data analysis using JMP, Minitab, or Design Expert software.
• Flexible and results oriented.
You should know: Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.
Why Kelly ® Science & Clinical?
Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.
About Kelly ®
At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re 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 Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.
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