R&D Mfg Scientist II - Stability Testing
R&D Mfg Scientist II - Stability Testing
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1 Vacancy
Job Description
Work Schedule
First Shift (Days)Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards Laboratory Setting Some degree of PPE (Personal Protective Equipment) required (safety glasses gowning gloves lab coat ear plugs etc.)Job Description
GROUP/DIVISION SUMMARY
The Drug Product Division - North America (DPD-NA) is one of the five divisions that make up the Pharma Services Group. We are made up of approximately 4400 colleagues across six sites who specialize in taking sterile injectable and oral solid dose drug products from development to commercialization.
POSITION SUMMARY
Provides routine analyses in a biochemistry environment within defined procedures and practices. Performs analytical methods for moderately sophisticated testing on samples stability and production intermediates to support process development and/or manufacturing operations. May research and implement new methods and technologies to improve operations. Makes detailed observations and reviews documents and communicates test results.
Key Responsibilities:
- Lead the validation of test methods for pharmaceutical raw materials and finished products for strength impurities identity potency and dissolution by HPLC GC dissolution spectroscopy and traditional quantitative analysis using HPLC GC LC/MS and compendial testing.
- Recognize and report out-of-specification or unexpected results and non-routine analytical and product problems.
- Write deviations OOS CAPA Change Controls SOP and specification documents.
- Perform daily instrument calibrations/verifications as required.
- Write and complete validation protocols in accordance with regulatory guidelines
- Review and interpret analytical test results; make recommendations based on data
- Run projects at the broad task level under supervision ensuring deliverables are met and next steps are clearly identified.
- Participate in meetings/teleconferences with clients. Develop methods and processes that meet or exceed the expectations from clients and provide innovation.
- Conducts routine tasks and sample analyses to support process development.
- Performs all duties in compliance with Standard Operating Procedures Good Manufacturing Practices Good Laboratory Practices and Safety guidelines. Maintains the compliance status required by company and facility standards.
Qualifications:
- Bachelor Degree in Chemistry Biochemistry Molecular Biology or related physical/biological science field minimally required with 3 years related experience or
- Masters degree 1 year related pharmaceutical industry experience strongly preferred.
- Experience with HPLC and Dissolution.
- Experience performing method development and validation chemical tests with chromatographic spectroscopic or other analytical techniques preferred
- Experience with EMPOWER preferred.
- Equivalent combinations of education training and meaningful work experience will be considered.
- Good knowledge and understanding of chemistry and analytical instrumental technologies.
- Good knowledge of qualitative and quantitative chemical or microbiological analysis.
- Awareness of quality and regulatory requirements in the pharmaceutical industry
- Strong interpersonal and communications skills written and oral
- Ability to read analyze and interpret technical procedures and governmental regulations.
- Excellent organization and planning skills.
- Strong attention to detail and ability to implement to standard procedures.
- Ability to design and complete tasks and studies based on the deliverables.
- Ability to accurately detail work and write reports.
Physical Requirements:
Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations. Ability to stand walk stoop kneel crouch periodically for prolonged periods of time Manipulation (lift carry move) of light to medium weights of 10-35 pound pounds. Arm hand and finger dexterity including ability to grasp and type for prolonged periods of time. Visual acuity to use a keyboard computer monitor operate equipment and read materials for prolonged periods of time. Ability to sit reach with hands and arms talk and hear for prolonged periods of time. Safety glasses safety shoes lab coat nitrile or similar gloves safety apron organic respirator occasionally.
BENEFITS
We offer competitive remuneration annual incentive plan bonus healthcare and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative forward-thinking organization and outstanding career and development prospects. We offer an exciting company culture that stands for integrity intensity involvement and innovation!
Our Mission is to enable our customers to make the world healthier cleaner and safer. Watch as our colleagues explain 5 reasons to work with us ( As one team of 100000 colleagues we share a common set of values - Integrity Intensity Innovation and Involvement - working together to accelerate research solve complex scientific challenges drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific where diverse experiences backgrounds and perspectives are valued.
APPLY TODAY!
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race color religion sex sexual orientation gender identity national origin protected veteran status disability or any other legally protected status.
ACCESSIBILITY/DISABILITY ACCESS
Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example this may include individuals requiring assistance because of hearing vision mobility or cognitive impairments. If you are a job seeker with a disability or assisting a person with a disability and require accessibility assistance or an accommodation to apply for one of our jobs please submit a request by telephone at 1-*. Please include your contact information and specific details about your required accommodation to support you during the job application process.
- This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes such as not being able to get into the career website following up on an application or other non-disability related technical issues will not receive a response.
Employment Type
Full-Time
