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Junior Scientist in Formulations
2 months ago
Impact of Your Role
As a Formulations Scientist, you will be responsible for producing products for the bulk formulations team while ensuring compliance with cGMP documentation. Your work will involve handling chemicals and biological materials to create reagents, calibrators, and controls intended for IVD immunoassay applications, along with engaging in process enhancement initiatives.
Key Responsibilities
- Produce various products such as reagents, calibrators, buffers, controls, and intermediates, while accurately completing batch records in accordance with cGMP and GDP standards.
- Conduct in-process testing utilizing clinical analyzers, followed by thorough data review and analysis.
- Evaluate batch records prepared by fellow manufacturing operators and scientists.
- Monitor and analyze lot histories to identify trends and discrepancies.
- Execute laboratory tasks including weighing, transferring, and mixing essential chemicals, as well as performing product filtration.
- Engage in process improvement projects aimed at enhancing operational efficiencies and addressing business requirements.
- Assist in modifying SOPs, work instructions, and reports under supervision.
- Initiate and support investigations into nonconformances and deviations.
- Maintain and troubleshoot equipment as necessary.
- Keep the department supervisor and/or manager informed of all relevant issues.
- Undertake additional job responsibilities as needed.
Qualifications Required
Education
- High school diploma or equivalent is mandatory.
- A Bachelor’s degree in a scientific discipline (preferably Chemistry or Biochemistry) is required.
- A combination of education and relevant experience may be considered.
Experience
- A minimum of 1 year of relevant experience and/or training is preferred.
- Experience in IVD immunoassay manufacturing is advantageous.
- Familiarity with handling potentially hazardous chemicals and human source materials is preferred.
- Knowledge of Quality System Regulations and ISO 13485 standards is a plus.
Skills and Abilities
- Proficient laboratory skills, including pipetting, safety protocols, and hazardous chemical handling.
- Capability to perform tasks in alignment with GMP, GDP, QSRs, ISO, and IVD regulations.
- Strong organizational skills and attention to detail to prioritize tasks effectively and meet productivity metrics.
- Self-motivated and focused individual.
Physical Requirements / Work Environment
- Ability to regularly lift up to 25 pounds.
Benefits Overview
We provide competitive compensation, an annual incentive plan, healthcare options, and a variety of employee benefits. Thermo Fisher Scientific is committed to fostering an innovative and forward-thinking work environment, offering excellent career development opportunities. Our company culture emphasizes integrity, intensity, involvement, and innovation.
Compensation and Benefits
The estimated salary range for this position is competitive, and it may also include a variable annual bonus based on individual and team performance in accordance with company policy. Our comprehensive Total Rewards package includes:
- A selection of national medical and dental plans, along with a national vision plan and health incentive programs.
- Employee assistance and family support programs, including commuter benefits and tuition reimbursement.
- At least 120 hours of paid time off (PTO), 10 paid holidays annually, and paid parental leave.
- Retirement and savings options, including a competitive 401(k) retirement savings plan.
- An Employee Stock Purchase Plan (ESPP) allowing eligible employees to purchase company stock at a discount.
