Manufacturing, Science and Technology Drug Product Lead
Job Description
Location Requirement:
This position may be based on either the U.S. West Coast (ideally near San Diego, CA) or the East Coast (ideally near Raleigh, NC or Boston, MA). The role requires periodic travel between both locations to support cross-site collaboration and business needs.
The Manufacturing, Science and Technology Drug Product Lead is responsible for:
ā¢ Subject matter expert (SME) and process owner for Drug Product (DP) manufacturing of a small molecule used in non-sterile dosage forms.
ā¢ Oversee all technical drug product manufacturing aspects (fully under GMP) for a small molecule manufactured at an external manufacturer.
ā¢ Lead the technical workstreams of product transfers from development to commercial site and between commercial sites, scale-up activities, process validations and oversees manufacturing of Drug product with a small molecule at external manufacturers for projects in clinical and commercial phase.
ā¢ Lead internal activities related to external manufacturing such as process change assessments, major/critical deviations, risk assessments and CAPAs
ā¢ Review and supervise set up, execution and documentation of DP related technical studies (CMC development and commercial operations), process and equipment qualifications and validations.
ā¢ Write and review applicable sections in registration files, variations and market expansion
ā¢ Issue, review and approve applicable internal and external SOP's and external manufacturer manufacturing instructions.
ā¢ Contribute during set up of new analytical specifications and stability programs and review changes thereof
ā¢ Support in sourcing evaluation of new Drug product small molecules, hard-gelatine capsule based alternative contract manufacturers and participation in developing supply and quality agreements.
ā¢ Be aware of external manufacturing technology advancements, understand and introduce new technologies and how they may be applicable to process innovation, cost or yield improvement
ā¢ Other job related tasks
Qualifications
Education/Learning Experience/Work Experience
ā¢ University education in Chemistry, Pharmacy or similar.
ā¢ +10 years of experience of development and manufacturing of oral dosage forms, drug products, with small molecules for clinical and commercial use.
Skills/Knowledge/Languages
ā¢ Recognized expert in Drug product manufacturing of hard-gelatine capsules.
ā¢ Scientific and technical background of CMC development and GMP-compliant manufacturing in for small molecule drug products.
ā¢ Demonstrable experience of working in cross functional team with ability to lead functional teams, prioritize and be an effective decision maker
ā¢ Experience of working with External manufacturers
ā¢ Experience of regulatory guidelines (FDA & EMA), regulatory authorities communication and filing documentation.
ā¢ Fluent in English, intermediate to full proficiency in Chinese is a plus.
Personal Attributes
ā¢ Strong cross-functional team player
ā¢ Ability to act independently and show strong ownership
Excellent communication skills, oral/written and listening to external and internal partners and stakeholders.
Additional Information
Compensation and Total Rewards at Sobi
At Sobi, we are dedicated to providing our employees with a comprehensive and industry-competitive total rewards package. Our compensation philosophy is designed to recognize and reward talent, ensuring that your contributions are valued and reflected in your overall rewards.
The base salary range for this role is $125,000-$165,000. Each individual offer will be determined based on several factors, including your experience, qualifications, and location. Additionally, this role is eligible for both short-term and long-term bonuses, as outlined in the plan details.
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Location Requirement:
This position may be based on either the U.S. West Coast (ideally near San Diego, CA) or the East Coast (ideally near Raleigh, NC or Boston, MA). The role requires periodic travel between both locations to support cross-site collaboration and business needs.
The Manufacturing, Science and Technology Drug Product Lead is responsible for:
ā¢ Subject matter expert (SME) and process owner for Drug Product (DP) manufacturing of a small molecule used in non-sterile dosage forms.
ā¢ Oversee all technical drug product manufacturing aspects (fully under GMP) for a small molecule manufactured at an external manufacturer.
ā¢ Lead the technical workstreams of product transfers from development to commercial site and between commercial sites, scale-up activities, process validations and oversees manufacturing of Drug product with a small molecule at external manufacturers for projects in clinical and commercial phase.
ā¢ Lead internal activities related to external manufacturing such as process change assessments, major/critical deviations, risk assessments and CAPAs
ā¢ Review and supervise set up, execution and documentation of DP related technical studies (CMC development and commercial operations), process and equipment qualifications and validations.
ā¢ Write and review applicable sections in registration files, variations and market expansion
ā¢ Issue, review and approve applicable internal and external SOP's and external manufacturer manufacturing instructions.
ā¢ Contribute during set up of new analytical specifications and stability programs and review changes thereof
ā¢ Support in sourcing evaluation of new Drug product small molecules, hard-gelatine capsule based alternative contract manufacturers and participation in developing supply and quality agreements.
ā¢ Be aware of external manufacturing technology advancements, understand and introduce new technologies and how they may be applicable to process innovation, cost or yield improvement
ā¢ Other job related tasks
Qualifications
Education/Learning Experience/Work Experience
ā¢ University education in Chemistry, Pharmacy or similar.
ā¢ +10 years of experience of development and manufacturing of oral dosage forms, drug products, with small molecules for clinical and commercial use.
Skills/Knowledge/Languages
ā¢ Recognized expert in Drug product manufacturing of hard-gelatine capsules.
ā¢ Scientific and technical background of CMC development and GMP-compliant manufacturing in for small molecule drug products.
ā¢ Demonstrable experience of working in cross functional team with ability to lead functional teams, prioritize and be an effective decision maker
ā¢ Experience of working with External manufacturers
ā¢ Experience of regulatory guidelines (FDA & EMA), regulatory authorities communication and filing documentation.
ā¢ Fluent in English, intermediate to full proficiency in Chinese is a plus.
Personal Attributes
ā¢ Strong cross-functional team player
ā¢ Ability to act independently and show strong ownership
Excellent communication skills, oral/written and listening to external and internal partners and stakeholders.
Additional Information
Compensation and Total Rewards at Sobi
At Sobi, we are dedicated to providing our employees with a comprehensive and industry-competitive total rewards package. Our compensation philosophy is designed to recognize and reward talent, ensuring that your contributions are valued and reflected in your overall rewards.
The base salary range for this role is $125,000-$165,000. Each individual offer will be determined based on several factors, including your experience, qualifications, and location. Additionally, this role is eligible for both short-term and long-term bonuses, as outlined in the plan details.
Apply tot his job
Apply To this Job