MSD
Technical Lead - Lyophilization/ Fill-Finish
MSD, Worthington, Minnesota, United States, 56187
Overview
Join our Global Animal Health Manufacturing (GAHM) Biotechnology Solutions (BTS) team as a leading scientific Commercial Lyophilization (Freeze Drying) expert. The Technical Lead, Lyophilization/Fill-Finish provides guidance, recommendations and judgment for strategic technical issues and decisions pertaining to commercial freeze drying (lyophilization) and fill-finish. The Technical Lead will ensure robust first principles-based tech-transfer and scale-up of lyophilization while working cross-functionally with our Animal Health Large Molecule strategy team, regional operations team and engineering teams involved in capital investment, technology transfer, and operational readiness to ensure scientific rigor.
Responsibilities
Build and maintain strong, trusting relationships with Manufacturing Division and Global Engineering leadership, and other stakeholders to ensure effective communication for scoping, planning and change management.
Stay abreast of scientific developments and trends in the fill-finish domain and participate in external industry/regulatory forums to maintain an industry-leading level of subject proficiency and foster continuous improvement.
Support scoping and planning of network manufacturing operations at a strategic level within the Animal Health division.
Serve as a leading scientific expert providing strategic guidance, recommendations and judgment for technical issues and decisions related to freeze-drying equipment, technology-transfer of inline cycles, and broader aseptic fill-finish technology with regard to Global Animal Health Manufacturing (GAHM) strategy. This position does not have employee management responsibilities.
Minimum Qualifications Education
Bachelor of Science or equivalent in a technical or scientific discipline such as Biology, Chemistry or Chemical Engineering
Preferred: PhD or advanced degree with specialization in a subject pertinent to vaccine/large molecule manufacture
A combination of both education and experience will be considered
Skills
At least seven years of relevant work experience in the vaccines, pharmaceutical, biotech, or related field.
Experience in analysis of commercial lyophilization processes for vaccines/large molecules/small molecules, in development, operational or technical support roles.
Strong scientific understanding of Animal Health vaccine and/or biologic products and processes and their integration with relevant regulatory/GMP requirements.
Preferred
Ability to collaborate effectively across functional boundaries to align stakeholders and sponsors on technical strategies.
Demonstrated problem solving, effective verbal and written communication, and people management skills.
Proficiency with pharmaceutical industry technical business processes: change control, deviation management, technical protocols/reports, and regulatory license documents.
Additional Information Current Employees and Current Contingent Workers apply through the company portal.
US and Puerto Rico Residents Only:
We are committed to inclusion and provide accommodations during the application or hiring process if needed.
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other legally protected characteristics. We comply with affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights; EEOC GINA Supplement.
We are proud to embrace diversity and inclusion and encourage collaboration across diverse experiences and perspectives.
Additional Employment Details U.S. Hybrid Work Model:
Effective September 5, 2023, U.S. office-based positions follow a Hybrid model of three on-site days per week (Mon-Thu) with Friday remote, subject to site variability and business needs. This does not apply to field-based, facility-based, manufacturing-based, or research-based positions, nor to roles designated as remote or covered by collective-bargaining agreements.
Salary:
The salary range for this role is $126,500.00 - $199,100.00. This reflects a range we believe is appropriate at the time of posting and can vary based on education, qualifications, certifications, experience, location, government requirements, and organizational needs.
Compensation and Benefits:
Eligible for annual bonus and long-term incentives, if applicable. Benefits include medical, dental, vision, retirement (401(k)), paid holidays, vacation, compassionate and sick days. More information about benefits is available at the company site.
Application:
You can apply through the corporate careers site. The posting includes an application deadline.
Additional Compliance:
San Francisco Fair Chance Ordinance applies for local applicants; Los Angeles Fair Chance Initiative applies as applicable.
Other:
Travel requirements up to 10%; Work arrangements: Hybrid; Shift: Day; Visa Sponsorship: No; Driving license required: Yes; Hazardous Materials: N/A.
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Join our Global Animal Health Manufacturing (GAHM) Biotechnology Solutions (BTS) team as a leading scientific Commercial Lyophilization (Freeze Drying) expert. The Technical Lead, Lyophilization/Fill-Finish provides guidance, recommendations and judgment for strategic technical issues and decisions pertaining to commercial freeze drying (lyophilization) and fill-finish. The Technical Lead will ensure robust first principles-based tech-transfer and scale-up of lyophilization while working cross-functionally with our Animal Health Large Molecule strategy team, regional operations team and engineering teams involved in capital investment, technology transfer, and operational readiness to ensure scientific rigor.
Responsibilities
Build and maintain strong, trusting relationships with Manufacturing Division and Global Engineering leadership, and other stakeholders to ensure effective communication for scoping, planning and change management.
Stay abreast of scientific developments and trends in the fill-finish domain and participate in external industry/regulatory forums to maintain an industry-leading level of subject proficiency and foster continuous improvement.
Support scoping and planning of network manufacturing operations at a strategic level within the Animal Health division.
Serve as a leading scientific expert providing strategic guidance, recommendations and judgment for technical issues and decisions related to freeze-drying equipment, technology-transfer of inline cycles, and broader aseptic fill-finish technology with regard to Global Animal Health Manufacturing (GAHM) strategy. This position does not have employee management responsibilities.
Minimum Qualifications Education
Bachelor of Science or equivalent in a technical or scientific discipline such as Biology, Chemistry or Chemical Engineering
Preferred: PhD or advanced degree with specialization in a subject pertinent to vaccine/large molecule manufacture
A combination of both education and experience will be considered
Skills
At least seven years of relevant work experience in the vaccines, pharmaceutical, biotech, or related field.
Experience in analysis of commercial lyophilization processes for vaccines/large molecules/small molecules, in development, operational or technical support roles.
Strong scientific understanding of Animal Health vaccine and/or biologic products and processes and their integration with relevant regulatory/GMP requirements.
Preferred
Ability to collaborate effectively across functional boundaries to align stakeholders and sponsors on technical strategies.
Demonstrated problem solving, effective verbal and written communication, and people management skills.
Proficiency with pharmaceutical industry technical business processes: change control, deviation management, technical protocols/reports, and regulatory license documents.
Additional Information Current Employees and Current Contingent Workers apply through the company portal.
US and Puerto Rico Residents Only:
We are committed to inclusion and provide accommodations during the application or hiring process if needed.
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other legally protected characteristics. We comply with affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights; EEOC GINA Supplement.
We are proud to embrace diversity and inclusion and encourage collaboration across diverse experiences and perspectives.
Additional Employment Details U.S. Hybrid Work Model:
Effective September 5, 2023, U.S. office-based positions follow a Hybrid model of three on-site days per week (Mon-Thu) with Friday remote, subject to site variability and business needs. This does not apply to field-based, facility-based, manufacturing-based, or research-based positions, nor to roles designated as remote or covered by collective-bargaining agreements.
Salary:
The salary range for this role is $126,500.00 - $199,100.00. This reflects a range we believe is appropriate at the time of posting and can vary based on education, qualifications, certifications, experience, location, government requirements, and organizational needs.
Compensation and Benefits:
Eligible for annual bonus and long-term incentives, if applicable. Benefits include medical, dental, vision, retirement (401(k)), paid holidays, vacation, compassionate and sick days. More information about benefits is available at the company site.
Application:
You can apply through the corporate careers site. The posting includes an application deadline.
Additional Compliance:
San Francisco Fair Chance Ordinance applies for local applicants; Los Angeles Fair Chance Initiative applies as applicable.
Other:
Travel requirements up to 10%; Work arrangements: Hybrid; Shift: Day; Visa Sponsorship: No; Driving license required: Yes; Hazardous Materials: N/A.
#J-18808-Ljbffr