JOB OBJECTIVE: Develop, characterize, validate, and perform
analytical methods for current and new products for a company that
manufactures small molecules, particles, and polymers used in
This position will be located at Promega's new Component
Manufacturing Center facility in Fitchburg. Please click on the
link to find more information regarding this facility's
functionality (CMC Building ).
1. Perform analytical method validation and characterization
when required to support process improvement, product transfer, or
new product realization projects.
2. Ability to independently perform all aspects of method
development and method validation. Product and raw material testing
would also be a function of this position.
3. Develop reports, protocols, and SOP’s for new and current
4. Mentor & train Junior scientists and aid when needed in high
throughput times of intermediate testing, final product, and raw
5. Maintain a working knowledge of QC Lab instrumentation and
associated analytical methods utilized for product release testing.
Perform analytical method evaluation and/or re-validation upon
request, as part of Installation / Operation / Performance
Qualification efforts related to new or changed laboratory
6. Evaluate and interpret analytical testing results. Act as
primary reviewer of analytical data generated from raw materials
test, In process testing, and final product testing.
7. Perform laboratory investigations for Out of Specification
results or other testing abnormality. Investigate complaints from
customers and internal deviations / nonconformances as
8. Develop and maintain a product/intermediate stability
9. Report results of release testing according to company
Quality System requirements. This includes the input of results
into SAP Quality Module and issuing COA’s as needed.
10. Prepare and/or maintain QC testing materials, retention
samples, and reference standards.
11. Write, review and revise, as necessary, Inspection Plans,
test methods, SOPs and other QC Dept procedures, for accurate and
complete content, and ensuring they meet documentation policy.
12. Provide training on QC methods and instrumentation in the
laboratory, as needed.
13. Understands and complies with ethical, legal and regulatory
requirements applicable to our business.
1. Degree in Chemistry or related lab science. MS with 2-4
years, or BS with 4-7 years direct experience in a Quality Control
lab using advanced equipment and techniques. Extensive experience
in method validation.
2. The ideal candidate will have extensive knowledge on the use
and troubleshooting of typical analytical instruments. These
include GC, ICP-OES, LC-MS, HPLC, NMR, Extinction Coefficients, and
3. Candidate will have a working knowledge of and the ability to
determine solubility, viscosity, TGA Fluorescence, mass, and
4. Knowledge with basic descriptive statistics such as mean,
standard deviation, confidence intervals, and linear regression.
Experience with use of statistical tools to analyze data.
5. The ideal candidate will have a proven track record in the
design of new and existing product method validation.
1. MS with 5-7 years experience in method development and
validation using HPLC, Mass Spectrometer, LC-MS, NMR, ICP-OES, GC,
NMR, Spectrophotometers or Luminometers.
2. Experience in a small molecule pharmaceutical API
3. Experience or familiarity with ISO9001 and/or cGMP
3. Independent, self-starter with proven results in problem
identification, planning, communication and project management.
4. Desire for future growth into QC department
5. Organizational and multi-tasking skills; able to manage
several tasks simultaneously.
1. Must be able to move about the building and labs while
performing the tasks described above.
2. Must be able to stand for long periods.
3. Must be able to identify and distinguish colors.
4. Ability to work with chemical reagents required for
5. Must be able to wear appropriate personal protective
equipment such as lab coat, mask, gloves and safety glasses.
6. Ability to move objects averaging 10 pounds.
7. Ability to travel.
8. Must be able to use a computer for extended periods of time
throughout the day.
Diversity is important at Promega. We are proud to be an Equal
Opportunity Employer, and make employment decisions without regard
to race, color, religion, sex, sexual orientation, gender identity,
national origin, veteran status, disability, or any other protected
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