Scientist II Process Development - Downstream

About the role

As the Downstream Process Development Scientist you will help our clients to deliver lifesaving and life changing therapies to patients. You will planning, executing, and documenting laboratory and tech transfer activities in support of process establishment, pilot, and transfer into cGMP manufacturing. You will also act as a subject matter expert (SME) and support a detailed transfer and operation of internally developed and client-transferred processes into the process development. You will also be supporting tech transfer out to the cGMP manufacturing space.

What will you do

• Contribute to multiple projects and participate in the planning and execution of process development and scale up activities (both bench and pilot scale)
• Serve as functional SME and work collaboratively with other team members on all aspects of upstream or downstream execution for viral vector processes
• Participate and/or own the training and development of other team members
• Prepare and modify documents (development plans, batch records, SOPs, protocols, summary reports)
• Identify technical gaps/facility fit challenges for new clients/processes
• Support analytical testing for process development and characterization

Education

• B.S. in Chemical Engineering, Biochemistry, Biology or related field with 3+ yrs of experience or Master's degree

General qualifications

• Demonstrate understanding of experimental design with the ability to independently conduct laboratory experiments
• Collaborate with the Analytical Development team to develop comprehensive testing plans
• Participate in client meetings to present results and assist with drafting process development reports
• Independently prepare or review Process Development records, work instructions, and batch records
• Design and conduct Design of Experiments (DOE) studies and high-throughput screenings tailored for either upstream or downstream process development
• Proficiency in technical writing, adhering to Good Documentation Practices (GDP), with preferred experience in data compilation and interpretation
• Flexibility in work hours, including availability for weekends and evenings to meet project timelines

Downstream Process Development Qualifications

• Expertise in various purification techniques, including affinity and anion exchange chromatography, with proficiency in using AKTA chromatography systems and Unicorn software
• Extensive experience with filtration-based unit operations such as tangential flow filtration, sterile filtration, and depth filtration
• Familiarity with viral clearance processes

Knowledge, Skills, Abilities

• Working level knowledge of downstream purification of mammalian and insect cell culture processes
• Experience in scale up and scale down of purification processes
• Understanding of cGMP and regulatory requirements of biopharmaceutical manufacturing
• Strong interpersonal and communications skills; written and oral
• Ability to function in a evolving environment & handle multiple priorities
• A flexible work schedule is required including Weekend and night as needed to support lab activities

Pay

The salary range estimated for this position based in Massachusetts is $72,600.00–$100,000.00. This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy.

Benefits

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs
• Employee assistance and family support programs, including commuter benefits and tuition reimbursement
• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
• Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

Schedule

Standard (Mon-Fri) with flexibility required including weekends and evenings to meet project timelines.

Work Environment

Able to lift 40 lbs. without assistance. Work settings include Cold Room/Freezers -22°F/-6°C, Laboratory Setting, Office, and some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.). Will work with hazardous/toxic materials.