Process Development Associate

Description:

Title: Process Development Associate

Location: Cambridge MA

Duration: 12 Months

Job Description:

• Ideal candidates will: work on downstream chromatography, including purification through use of AKTAs and NFF/TFF filtration systems, process sampling and sample submission, utilizing high throughput technologies (e.g. TECAN), experimental documentation in electronic notebook system, and being involved in data compilation and analysis. Must have lab experience and at least one year working on similar projects.
• The Pivotal Drug Substance Technologies organization at develops, characterizes and supports clinical drug substance manufacturing processes for all late-stage programs in the portfolio.
• This lab-based position is located at our Cambridge, MA site. The successful candidate will be responsible for support of the development, characterization, scale-up and support of upstream and downstream processes to enable clinical advancement of programs. The candidate will also be responsible for equipment maintenance and reliability. This role will include project-based work managed by the candidate.
• This role is in an integrated bioprocess development group in which cell culture and purification scientists work together to advance rich, exciting and dynamic pipeline. With biology first approach, the position provides the unique opportunity to work on multiple modalities including antibodies, BiTEs, bispecifics and ADCs.
• The successful candidate will design and execute experiments at the bench scale, spanning the end-to-end drug substance process, including both cell culture and purification operations. The candidate will apply established platform approaches and utilize problem-solving skills to rapidly solve day-to-day experimental challenges. Additionally, the candidate will utilize out-of-the-box thinking to contribute to laboratory operations, technology development, and process automation. Finally, the candidate will also expand and develop skills in both cell culture and purification, thereby further contributing to the integrated group.

Must Haves:

• Bachelors or Masters degree
• Chromatography experience
• Filtration experience
• Hands on lab experience
• Nice to have: AKTA prior working experience (non educational)

Preferred Qualifications:

• Master’s degree in Chemical Engineering, Biochemical Engineering, Life Sciences, or other relevant sciences with a demonstrated record of excellence.
• Ability to identify, develop and implement solutions to practical problems through application of fundamental scientific and engineering principles, preferably in a process development environment.
• Basic understanding of cell culture and/or protein chromatography and filtration principles; hands-on experience with mammalian cell culture, and/or purification operations is a plus.
• Prior experience with data analytical tools (Excel, Spotfire, etc.) and experience with statistical analysis and programming in JMP, R, and/or Python environments is a plus.
• Motivated self-starter with excellent interpersonal and organizational skills. Team player with the ability to successfully work within a diverse team in a dynamic, cross-functional environment.
• Familiarity with design of experiments and statistical analysis of data desirable.
• Prior experience with data analytical tools (Excel, Spotfire, Python etc.).
• Prior experience with project management is a plus.

Salary and Other Compensation:

The annual [salary/hourly rate] for this position is between $25.00 - 26.00 per hour . Factors which may affect pay within this range may include geography/market, skills, education, experience, and other qualifications of the successful candidate.

Benefits:

The Company offers the following benefits for this position, subject to applicable eligibility requirements:

[medical insurance], [dental insurance], [vision insurance], [401(k) retirement plan], [life insurance], [long-term disability insurance], [short-term disability insurance],

[paid parking/public transportation], [Paid time off], [Days/hours of paid sick and safe time], [Days/hours of paid vacation time], [Weeks of paid parental leave], [Paid holidays annually], [any additional benefits applicable].