Sr. Engineer, Manufacturing Sciences

3 weeks ago

Lexington, United States Genezen Full time

The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new cures.

WORKING AT GENEZEN

Many people have worked in environments where you feel like just another nameless part of an enormous machine. Genezen is different. We want our employees to be innovative, collaborative problem solvers who are dedicated to meeting the challenges of working at a fast-growing company. We are dedicated to empowering our employees to be their best and making Genezen a rewarding place to work. Every employee contributes to the success of the company and you can be part of that team.

JOB SUMMARY

The Global Manufacturing Sciences & Technology (MSAT) group plays a critical role in successful manufacturing of clinical and commercial products. The person in this role assists the MSAT team in the transfer of technologies, process validation and cGMP manufacturing of Genezen's gene therapy products.

JOB RESPONSIBILITIES:

  • Lead all aspects of process technology transfer from early and late-stage process development for clinical and commercial manufacturing.
  • Provide technical support to manufacturing, and write product impact assessments to support deviations.
  • Provide input on scope of work proposals to ensure client's goals are met.
  • Cross functionally collaboration with Process Development, Manufacturing, QC, QA, Engineering, Regulatory Affairs, Validation and Supply Chain as needed
  • Ensure successful manufacturing production runs by assessing risk, setting preventative measures in place, investigating, and troubleshooting equipment and process issues.
  • Ability to provide impact assessments and aid in root-cause analysis for critical deviations and determine CAPAs for manufacturing.
  • Author and review technical documentation: batch records, SOPs, protocols, and reports.
  • Assist process validation studies to develop a thorough understanding of operating and performance parameters.
  • Support data monitoring and trending analysis using statistical process control charts.
SPECIAL JOB REQUIREMENTS
  • Adaptability required as work schedule may change based on business needs
  • Criminal background check required
  • Other duties as assigned
KNOWLEDGE, SKILLS AND EXPERIENCE

EDUCATION / CERTIFICATIONS / LICENSES

Essential/Desired

Bachelor's Degree in Engineering or other related scientific discipline.

Essential

Master's Degree in Engineering or other related scientific discipline.

Desired

ON-THE-JOB EXPERIENCE

6+ (BS) or 4+ (MS) or 0-2 (PhD) years of relevant experience in gene therapy or other biotechnology industry.

Essential

SKILLS / ABILITIES

Experience in process development/analytical development/MSAT or GMP pharmaceutical manufacturing.

Essential
Good understanding of upstream and downstream processes of viral vectors, cell therapy, or recombinant biologics.
Essential

Ability to present to and interact with clients on behalf of the MSAT team

Essential

Experience developing and executing tech transfer into GMP manufacturing.

Essential

Ability to generate, manage, evaluate, and maintain critical data in a highly organized manner

Essential

Experience with statistical analysis of process data (generation and trending control charts, linear regression and multivariate analysis)

Essential

Strong communication skills at individual, team, and organizational levels; fluent in English, written and verbal.

Essential

Proven knowledge and experience of risk-based approaches to process development and validation.

Essential

Demonstrated sufficient knowledge and experience in cell culture and cell & virus banking.

Essential

Ability to cope with many topics in parallel, to cope with strict timelines and to handle pressure.

Essential

Ability to generate, manage, evaluate, and maintain critical data in a highly organized manner.

Essential

Knowledge of the current pharmaceutical, regulatory, and technology trends.

Desired

Knowledge of data management tools and statistical process controls.

Desired

PHYSICAL DEMANDS

While performing the duties of this job, the employee is required to meet the following physical demands:

Work Environment
  • Regularly sit for long periods of time
Movement
  • Frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms
  • Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl
Lifting
  • Frequently lift and/or move up to 10 pounds
  • Occasionally lift and/or move up to 25 pounds
Vision
  • Frequently utilize close vision and the ability to adjust focus
Communication
  • Frequently required to communicate by talking, hearing, using telephone and e-mail
GENEZEN'S CURES VALUE-BASED COMPETENCIES

Committed to Science
We are committed to scientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare.

Urgency in action for the patients
We operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs.

Resilience & Grit in operations
We are committed to overcoming challenges, learning from failures, and persistently striving for success.

Execute with Excellence & Integrity
We are dedicated to delivering quality results and upholding ethical principals.

Solutions driven for our partners
We are committed to being a proactive, collaborative, creative and open-minded partner.

GENEZEN'S BENEFITS
  • Paid vacation days, amount based on tenure
  • Paid sick time
  • 9 observed holidays + 1 floating holiday + 1 volunteer day
  • 401(k) plan with company match up to 6% of salary, vested immediately
  • Share Appreciation Rights
  • Choice of several healthcare plans
  • FSA and HSA programs
  • Dental & vision care
  • Employer-paid basic term life/personal accident insurance
  • Voluntary disability, universal life/personal accident insurance
  • Accidental Death & Dismemberment (AD&D) Insurance
ADDITIONAL DETAILS
  • Nothing in the job description for this role restricts management's right to assign or reassign duties and responsibilities to this job at any time.
  • This position requires a criminal background check.
  • Genezen is an Equal Opportunity Employer.
  • Genezen participates in EVerify.
  • Genezen is interested in every qualified candidate who is eligible to work in the United States; however, we are not able to sponsor visas.

Genezen has operates two locations: one in Fishers, Indiana and the second in Lexington, Massachusetts.

Fishers is a suburb of Indianapolis. Fishers was named the #1 place to live in the US by Money Magazine in 2017 for its livability, safety and entrepreneurship. Fishers is one of the fastest growing communities in Indiana and is dedicated to supporting a high quality of life for all its residents. Nearby Indianapolis is home to professional and college sports teams, the Indy 500, a growing art community and the world's largest children's museum--to name just a few reasons why this area is a great place to live.

Lexington, Massachusetts, located just northwest of Boston, is renowned as a historic suburb with a rich cultural heritage. It boasts picturesque New England charm, tree-lined streets, and a vibrant community. Known for its pivotal role in the American Revolution, Lexington offers visitors and residents alike a blend of historical landmarks, modern amenities, and a strong sense of community pride.

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