Senior Staff Scientist - Process Development - MSAT
Apply NowCompany: Mayo Clinic
Location: Rochester, MN 55901
Description:
Job Description
This position can be located at one of our three major campuses in Phoenix/Scottsdale, Arizona, Jacksonville, Florida or Rochester, MN.
Work unit scientist who develops, leads, innovates, and evaluates biomanufacturing process improvements; facilitates transition of new products into manufacturing and provides technical expertise and troubleshooting during manufacturing operations supporting approved standard operating procedures (SOPs) and product validation for FDA-regulated, cGMP compliant manufacturing operations.
Responsibilities will include leading design and execution of studies in support of clinical translation of novel biotherapeutics, targeting manufacturing science and technology (MSAT) in CRB. Optimization and investigation of process issues to target process scale for improvement of existing methods or implementation of novel technology of proven validity. Supervises junior scientific staff and provides direction to junior scientists and process development technologists. Assists in analysis of data. Reviews and signs off on SOPs, technical studies and reports, batch documentation and laboratory notebooks in a compliant manner. Participates in drafting regulatory documentation for FDA submission. Participates in forecasting project budgetary needs.
Guides the development of release test methods, maturation of research analytical methodology into development and cGMP, and analytical method technology transfer from and to our facilities and/or contract vendors. Plans, guides and assists in executing laboratory studies to optimize and troubleshoot manufacturing processes, ensuring alignment with regulatory requirements. Oversight on readying project transition into clinical manufacturing. Trains manufacturing personnel in final product manufacturing processes.
Qualifications
About Us
Why Mayo Clinic
Mayo Clinic is top-ranked in more specialties than any other care provider according to U.S. News & World Report. As we work together to put the needs of the patient first, we are also dedicated to our employees, investing in competitive compensation and comprehensive benefit plans - to take care of you and your family, now and in the future. And with continuing education and advancement opportunities at every turn, you can build a long, successful career with Mayo Clinic. You'll thrive in an environment that supports innovation, is committed to ending racism and supporting diversity, equity and inclusion, and provides the resources you need to succeed.
Benefits Highlights
About the Team
Just as our reputation has spread beyond our Minnesota roots, so have our locations. Today, our employees are located at our three major campuses in Phoenix/Scottsdale, Arizona, Jacksonville, Florida, Rochester, Minnesota, and at Mayo Clinic Health System campuses throughout Midwestern communities, and at our international locations. Each Mayo Clinic location is a special place where our employees thrive in both their work and personal lives. Learn more about what each unique Mayo Clinic campus has to offer, and where your best fit is.
Affirmative Action and Equal Opportunity Employer
As an Affirmative Action and Equal Opportunity Employer Mayo Clinic is committed to creating an inclusive environment that values the diversity of its employees and does not discriminate against any employee or candidate. Women, minorities, veterans, people from the LGBTQ communities and people with disabilities are strongly encouraged to apply to join our teams. Reasonable accommodations to access job openings or to apply for a job are available.
This position can be located at one of our three major campuses in Phoenix/Scottsdale, Arizona, Jacksonville, Florida or Rochester, MN.
Work unit scientist who develops, leads, innovates, and evaluates biomanufacturing process improvements; facilitates transition of new products into manufacturing and provides technical expertise and troubleshooting during manufacturing operations supporting approved standard operating procedures (SOPs) and product validation for FDA-regulated, cGMP compliant manufacturing operations.
Responsibilities will include leading design and execution of studies in support of clinical translation of novel biotherapeutics, targeting manufacturing science and technology (MSAT) in CRB. Optimization and investigation of process issues to target process scale for improvement of existing methods or implementation of novel technology of proven validity. Supervises junior scientific staff and provides direction to junior scientists and process development technologists. Assists in analysis of data. Reviews and signs off on SOPs, technical studies and reports, batch documentation and laboratory notebooks in a compliant manner. Participates in drafting regulatory documentation for FDA submission. Participates in forecasting project budgetary needs.
Guides the development of release test methods, maturation of research analytical methodology into development and cGMP, and analytical method technology transfer from and to our facilities and/or contract vendors. Plans, guides and assists in executing laboratory studies to optimize and troubleshoot manufacturing processes, ensuring alignment with regulatory requirements. Oversight on readying project transition into clinical manufacturing. Trains manufacturing personnel in final product manufacturing processes.
Qualifications
- PhD in biological science, chemistry, immunology, cell/molecular biology, bioengineering or other related science from an accredited institution with 8 plus years of relevant industry/academia experience in production of biotherapeutics.
- Prefer MSAT experience
- Self-motivated, highly organized, efficient, and able to work independently exercising strong decision-making skills.
- Excellent written and verbal communication skills are necessary.
- Capable of reproducing a reference method using available procedures without supervision.
- Demonstrated analytical and scientific competency with process development and/or validation of lab techniques or procedures.
- Experience with various data collection and organizational systems, analysis and delivery of information.
- Experience managing scientific staff.
About Us
Why Mayo Clinic
Mayo Clinic is top-ranked in more specialties than any other care provider according to U.S. News & World Report. As we work together to put the needs of the patient first, we are also dedicated to our employees, investing in competitive compensation and comprehensive benefit plans - to take care of you and your family, now and in the future. And with continuing education and advancement opportunities at every turn, you can build a long, successful career with Mayo Clinic. You'll thrive in an environment that supports innovation, is committed to ending racism and supporting diversity, equity and inclusion, and provides the resources you need to succeed.
Benefits Highlights
- Medical: Multiple plan options.
- Dental: Delta Dental or reimbursement account for flexible coverage.
- Vision: Affordable plan with national network.
- Pre-Tax Savings: HSA and FSAs for eligible expenses.
- Retirement: Competitive retirement package to secure your future.
About the Team
Just as our reputation has spread beyond our Minnesota roots, so have our locations. Today, our employees are located at our three major campuses in Phoenix/Scottsdale, Arizona, Jacksonville, Florida, Rochester, Minnesota, and at Mayo Clinic Health System campuses throughout Midwestern communities, and at our international locations. Each Mayo Clinic location is a special place where our employees thrive in both their work and personal lives. Learn more about what each unique Mayo Clinic campus has to offer, and where your best fit is.
Affirmative Action and Equal Opportunity Employer
As an Affirmative Action and Equal Opportunity Employer Mayo Clinic is committed to creating an inclusive environment that values the diversity of its employees and does not discriminate against any employee or candidate. Women, minorities, veterans, people from the LGBTQ communities and people with disabilities are strongly encouraged to apply to join our teams. Reasonable accommodations to access job openings or to apply for a job are available.