Process Development Associate

BioSpace; Milford (MA); On-site; USD 70,000 - 110,000; Full time

Job summary

Boston BioProducts seeks a Process Development Associate to support new product introductions and ensure products meet customer specs and quality standards. The role focuses on feasibility, scalability, and continuous improvement while maintaining high standards for customers.

This is a 100% onsite position in Milford, MA with local candidates preferred. The candidate will work closely with the PD Manager and cross-functional teams to drive product development and process optimization.

Qualifications

• Bachelor's degree in Biology, BioChemistry or related discipline required.
• Minimum of 2-3 years in GMP, ISO, or manufacturing environment.
• Ability to perform calculations for new and existing products.
• Ability to meet deadlines, multitask, and adapt priorities while maintaining productivity.

Responsibilities

• Calculate, perform, verify and review chemical product formulations.
• Onboard new products following BBP procedures and standards (documentation, feasibility, scalability, consistency, verification).
• Generate manufacturing batch records and translate customer requirements into technical instructions for manufacturing.
• Create pilot, verification, and investigational batches.
• Assist in 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.
• Calibrate, qualify, validate, and perform preventative maintenance on equipment.
• Review previous processes, SOPs, and procedures for potential improvement.
• Train staff on new procedures, equipment usage, lab and chemical safety.
• Ensure proper disposal of all products per Safety Data Sheet.
• Work on new projects assigned by Process Development Manager.

Skills

Calculations

Multitasking

Project coordination

Team collaboration

Independent work

Education

Bachelor's degree in Biology/BioChemistry or related

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

• Direct Applicants ONLY - No Staffing Agencies or Third-Party Recruiters.

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.
• Calibrate, qualify, validate, and perform preventative maintenance on equipment
• 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