Process Development Associate

BioSpace; Milford (MA); On-site; USD 70,000 - 90,000; Full time

Job summary

Boston BioProducts is expanding its Process Development team and seeks a PD Associate to support new product introductions, ensure customer specs and quality, and drive process improvements. The role is 100% onsite in Milford, MA with local candidates preferred.

The ideal candidate has a Bachelor's degree in Biology/Biochemistry and 2–3 years of GMP/ISO manufacturing experience, with strong calculation and collaboration skills.

Qualifications

• Bachelor's degree in Biology, Biochemistry or related discipline.
• Minimum 2-3 years GMP/ISO manufacturing experience.
• Ability to perform calculations for new and existing products.
• Ability to meet deadlines, multitask and prioritize while maintaining productivity.

Responsibilities

• Calculate and review chemical product formulations.
• Onboard new products following BBP procedures and standards.
• Generate manufacturing batch records and translate customer requirements into technical instructions.
• Create pilot, verification, and investigational batches.
• Assist in investigations for complaints, verifications or new procedures.
• Draft, review and update SOPs, Work Instructions, Memos and Safety Data Sheets.
• Coordinate with clients and vendors to ensure timelines and projects are completed.
• Forecast and provide minimum quantities of raw materials, chemicals and consumables.
• Support business development, sales and production to meet deadlines.
• Review previous processes and SOPs for potential improvements.
• Train staff in new procedures, equipment usage and lab safety.
• Ensure proper disposal of products per SDS.
• Work on new projects assigned by Process Development Manager.

Skills

Process development

GMP

ISO

Batch records

Education

Bachelor's degree in Biology

Bachelor's degree in Biochemistry

Job description

As Boston BioProducts continues to grow, we are expanding our Process Development (PD) team and are seeking a Process Development (PD) Associate. This role is instrumental in supporting new product introductions by ensuring products meet customer specifications and quality expectations. The PD Associate will also evaluate the feasibility, scalability, and accuracy of products and processes while driving continuous improvements that enhance efficiency, consistency, and overall quality. As we continue to scale, this position plays an important role in maintaining the high standards our customers expect.

This is a 100% (Mon-Fri) onsite role in Milford, MA - LOCAL CANDIDATES ONLY

Responsibilities

• Calculate, perform, verify and review chemical product formulations
• Onboards new products following BBP procedures and standards (documentation, feasibility, scalability, consistency, and verification)
• Generates manufacturing batch records and translates customer requirements into technical instructions for manufacturing
• Create pilot, verification, and investigational batches
• Assist in performing investigations for complaints, verification or new procedures
• Draft, review and update SOPs, Work Instructions, Memos, Safety Data Sheets, etc.
• Communicate with clients and vendors to ensure timelines and projects are completed.
• Forecast and provide minimum quantities of raw materials, chemicals and consumables.
• Supports business development, sales and production to ensure projects meet the set deadlines
• Review previous processes, SOPs, and procedures for potential improvement
• Training staff in new procedures, equipment usage, lab and chemical safety
• Ensuring that all products are properly discarded in accordance with the Safety Data Sheet
• Work on new projects assigned by Process Development Manager as they arise

Education

Bachelor's degree in Biology, BioChemistry or any related discipline

Experience

Minimum of 2-3 years working in a GMP, ISO or manufacturing environment

Knowledge & Skills

• Includes all Knowledge and Skills of a Process Development Associate I
• Ability to perform calculations for new and existing products
• Ability to meet deadlines, multitask, and change priorities while maintaining productivity
• Ability to coordinate internally and externally with BBP team members and clients to ensure project completion.
• Ability to work well independently and within a team

Physical Requirements

• Stand and work in a lab environment for an extended period
• Ability to Lift and Transfer up to 25 pounds
• Work underneath a Biological Safety Hood for an extended period