Formulation Scientist I

4 weeks ago


Middletown, United States Thermo Fisher Scientific Full time

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Thermo Fisher Scientific offers its full-time employees a range of benefits including: a strong benefit package with the ability to choose a program that best fits your needs, effective on the first day of employment; 401K with 100% company match on first 6%; gainshare program with quarterly payouts of 5% target; 16 days PTO after 1st year (15 days prorated in first year of hire); standard work hours with no shift rotation; discount program exclusively for Thermo Fisher Scientific employees that gives you access to thousands of items and perks at discounted prices; clean temperature controlled environment; employee and family activities; strong partnership with our community; and the ability to make a difference in people’s lives.

**Position Summary**

Work in a Value Stream environment and organize, carry out, monitor, multi-stage production processes to prepare and formulate serum, clinical diagnostic assays and reagents for use in research and commercial scientific products for the IVD industry with compliance to specifications and GMP/FDA requirements. The formulations range in scale from 1 mL to 50,000 L and are manufactured using protocols/batch records in an environmentally monitored lab space. Data is recorded in batch records following good documentation practices as required for regulated industries.

**What will you do?**
- Calculate raw material volumes required for each batch by referencing amounts necessary to meet manufacturing schedule and product specifications.
- Follow detailed processing documentation, processes base serums, Clinical Chemistry reagents, intermediates and final serum products.
- Plan all intermediates at proper times in the formulation cycle to ensure that all target production dates for final product formulation are met.
- Prepare and inspect equipment for use in chemical and bio-formulations. Set up pumps, filters, tubing connections and mixers.
- Follow prescribed directions to calculate the amount of chemical needed to formulate the volume of the product specified in the production schedule. Weigh and mix chemicals with diluents under controlled conditions.
- Responsible for the cleaning and routine maintenance of all equipment.
- Maintain complete and accurate production records in conformance with GMP and FDA requirements.
- Perform basic laboratory analytical testing.
- Ability to successfully perform a line opening and line closing.
- Input data into a computerized material control system.
- Continuously monitors work area for unsafe conditions and take immediate action to correct unsafe condition(s).
- Responsible for quality of product produced.
- Ability to operate lifting equipment if required.
- Continuously follows all safety requirements including PPE.
- Performs other duties as assigned.

**Minimum Requirements/Qualifications**:

- High School Diploma or equivalent; a B.S. in Science or Medical Technology is preferred. Minimum of one year production experience (may be waived in lieu of B.S. in Science) and knowledge of the metric system (weights & volumes). Relevant education may be considered in lieu of one year production experience.

**Non-Negotiable Hiring Criteria**:

- Must have excellent math and communication skills and working knowledge of the metric system (weights & volumes).
- Proven problem solving skills
- Demonstrated ability to organize and prioritize work
- Familiarity with various internal production processes
- Knowledge of GMP and ISO requirements
- Ability to work effectively with team members at all levels
- Familiarity with SAP transactions is a plus
- Flexible around work hours, available for overtime, as necessary (may include extended shifts & weekends)
- Ability to follow written and oral instructions
- Demonstrated good safety and quality practices
- Good attendance history is required.

**Physical Requirements**:

- Normal manufacturing environment.
- Position may require frequent communication and walking to other areas in which designated PPE will be required.
- Must be able to successfully complete a Respirator Fit Test within 6 months of hire.
- Position will require sitting and standing.
- Ability to lift materials weighing up to 110 pounds. Employee to employ traditional lift ing techniques for materials up to 75 lbs. Items over 75 lbs will require the employee to use non traditional techniques including, push-pull method, automated lifts and other equipment o



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