Scientist III, Manufacturing Sciences
Share
Job Location:
Plainville, CT - USA
Monthly Salary:
$ 83300 - 125000
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Work Schedule
Standard (Mon-Fri)Environmental Conditions
Cleanroom: no hair products jewelry makeup nail polish perfume exposed piercings facial hair etc... allowed OfficeJob Description
MST Process Engineer/Scientist III Downstream PLA
JOB SUMMARY/OBJECTIVE:
The primary responsibility is to participate in Manufacturing Sciences and Technology activities in support of downstream technology transfer late stage clinical PPQ and commercial manufacturing of viral vectors. The individual will serve as a process expert in downstream processing. This position requires close interaction with MS&T colleagues Project Management Manufacturing Quality Assurance Quality Control Process Development Engineering Supply Chain and other departments. This role will focus on aspects of implementing manufacturing processes to produce early- and late-phase human clinical trial and commercial gene therapy products.
RESPONSIBILITIES:
- MST process lead for Downstream technology transfer activities involved in manufacturing viral vectors following cGMP guidelines.
- Collaborate with other sites or clients to ensure success of process transfer and scale up.
- Ensure effective information flow risk assessment timeline execution issue resolution and documentation for multi-departmental teams (Process Development Manufacturing Quality and Project Management).
- Includes authoring detailed process definition facility fit and raw material risk assessments.
- Author PPQ protocols and reports. Oversee execution of PPQ and PPQ related activities
- Develop sampling plans with clients and incorporate them into cGMP batch documentation.
- Monitor and trend process performance including input and output parameters.
- Find opportunities to improve systems and practices
KNOWLEDGE SKILLS and QUALIFICATIONS:
- A degree in biochemical engineering chemical engineering or related scientific field such as molecular biology virology biochemistry. Advanced degree preferred.
- B.S. with 8 years Masters degree with 6 years or PhD with 3 years professional history.
- Technical expertise in downstream biopharmaceutical manufacturing and/or process with automated chromatography systems (AKTA) and automated tangential flow filtration (Repligen).
- Expertise in late stage/commercial technology transfer process characterization and process validation biopharmaceutical/gene transfer vector manufacturing preferred.
- Knowledge of GMP and regulatory requirements of biopharmaceutical manufacturing specifically cell and gene therapy vector production
- Ability to work both independently and as part of a team.
- Proficiency in operating effectively in a fast-paced dynamic environment while juggling multiple projects
- Project management skills desirable
- Ability to speak effectively before groups of customers.
- Excellent investigational skills and ability to solve technical issues. Ability to compile analyze and interpret data; Ability to write routine reports and correspondence.
- Strong interpersonal skills to facilitate verbal and written communication.
Excellent Benefits
- Benefits & Total Rewards Thermo Fisher Scientific
- Medical Dental & Vision benefits-effective Day 1
- Paid Time Off & Designated Paid Holidays
- Retirement Savings Plan
- Tuition Reimbursement
OTHER
- Relocation assistance is not provided.
- Must be legally authorized to work in the United States now and in the future without sponsorship.
- Must be able to pass a comprehensive background check which includes a drug screening
Compensation and Benefits
The salary range estimated for this position based in Massachusetts is $83300.00$125000.00.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. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on which includes:
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
Key Skills
- Laboratory Experience
- Immunoassays
- Machine Learning
- Biochemistry
- Assays
- Research Experience
- Spectroscopy
- Research & Development
- cGMP
- Cell Culture
- Molecular Biology
- Data Analysis Skills
About Company
Electron microscopes reveal hidden wonders that are smaller than the human eye can see. They fire electrons and create images, magnifying micrometer and nanometer structures by up to ten million times, providing a spectacular level of detail, even allowing researchers to view single a ... View more
