Downstream Development Engineer – Pilot Operations

Job Description

The Downstream development engineer will support Pilot lab operations within R&D that serves as the critical interface between lab-scale development and full-scale manufacturing. The individual will independently execute both routine and complex operations participate in planning unit operations/experiments draft support documentation (SOPs batch records and/or reports) and analyze data (Spotfire or similar). They will apply knowledge from various technical areas industry practices and standards and will provide quality and productive output that is consistently timely reliable and reproducible. The candidate should possess experience and knowledge of activities routinely performed in downstream (e.g. Harvest Clarification Chromatography Filtration and buffer preparation) Previous Experience with AKTA systems and Unicorn Software is preferred. Additionally knowledge of Upstream Purification activities (e.g. vial thaw cell culture expansion large scale bioreactor setup and control centrifugation/depth filtration and media/buffer preparation) is appreciated. This role is predominantly lab-based and will interact closely with counterparts in Process Development and Manufacturing Sciences to support tech transfer of developed/locked processes.

Accountabilities:

80% - Pilot-Scale Cell Culture Campaigns:

• Execute non-GMP Downstream Purification operations at pilot scale (50-1000L) to support new product development material supply process improvements and demonstration runs for various programs across the whole development lifecycle including post-launch commercial processes.
• Partner with other process development and manufacturing sciences teams to troubleshoot and resolve process challenges and support large-scale studies.
• Coordinate and manage critical process details including long-lead item tracking sample planning material ordering and vendor interactions.
• Independently record analyze and interpret process data identifying patterns and trends.
• Present findings and technical issues at departmental and project meetings proposing solutions and implementing corrective actions under supervision.
• Contribute to pilot-scale procedures and documentation.
• Support global tech transfers.
• Support the authoring of technical reports protocols and internal presentations. Assist team members with scientific publications external abstracts and conference presentations as required.

20% - Technology and Digital Innovation:

• Evaluate and integrate novel pilot-scale technologies and digital tools to establish a versatile platform supporting multiple bioprocesses.
• Drive continuous improvement through the adoption of innovative solutions to enhance efficiency data analytics and operational performance.

Qualifications :

• Bachelors degree in Chemistry Biology Pharmacy Engineering or related pharmaceutical science with 2 years of relevant industry experience OR a Masters degree in related fields (industry experience preferred but not required).
• Experience with downstream purification processes is required.
• Hands-on experience with downstream activities such as chromatography ultrafiltration/diafiltration (UF/DF) tangential flow filtration (TFF) and depth/sterile filtration.
• Experience supporting nonGMP batches within an R&D Pilot Plant environment operating at the 501000 L bioreactor scale (interface between labscale and fullscale GMP manufacturing).
• Experience with AKTA chromatography systems and Unicorn software preferred.
• Strong analytical and problemsolving abilities; able to troubleshoot technical issues using data and scientific judgment.
• Effective collaborator with the ability to work well within crossfunctional teams.
• Clear and concise communicator with strong documentation practices and the ability to escalate issues appropriately.
• Strong organizational skills with the ability to manage multiple priorities and meet deadlines.
• Proficient in operating and maintaining relevant laboratory equipment; familiarity with upstream processes is a plus.
• Ability to wear required PPE (safety glasses/goggles gloves safety shoes).
• Ability to lift push or pull up to 25 lbs stand for up to 4 hours and climb ladders/work platforms or bend/stoop to inspect equipment.
• Must be authorized to work in the United States indefinitely without restriction or sponsorship.

Additional Information :

What to Expect in the Hiring Process:

• 10-15 Minute Phone Interview with Region Recruiter
• 45-60 Minute Virtual Interview with Manager and/or Group Leader
• 45-60 Minute Onsite to Meet the Team 

The position is Full Time Monday-Friday 8am-5pm. Candidates currently living within a commutable distance of Lexington MA are encouraged to apply.

What We Offer:

• Excellent full-time benefits including comprehensive medical coverage dental and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays
• Yearly goal-based bonus & eligibility for merit-based increases
• Hourly rate is between $30-34

Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.

Remote Work :

No

Employment Type :

Full-time