We are looking for an Associate Scientist, Quality Control. This position is an on-site role requiring a five (5) days per week, Monday-Friday, at our Minneapolis production facility in New Hope, MN, which is a cGMP production manufacturing facility for our product lines.
Job duties:
- Develop and validate analytical methods for the quantification and qualification of drug substances, excipients, and finished products.
- Review and interpret laboratory data, ensuring accuracy and consistency in test results through the use of statistical quality control techniques.
- Investigate out-of-specification (OOS) results and implement corrective actions to prevent recurrence, documenting all findings and procedures.
- Maintain and calibrate analytical instruments and laboratory equipment to ensure precise and accurate testing capabilities.
- Prepare detailed reports and documentation that summarize test results, methodologies, and any deviations from standard procedures.
- Collaborate with research and development (R&D) teams to support the development of new products and the improvement of existing formulations.
- Manage the disposal of hazardous materials and chemicals in accordance with environmental and safety regulations, ensuring a safe laboratory environment.
- Perform analytical testing on raw materials, in-process samples, and finished products to ensure compliance with quality standards and regulatory requirements.
- Authors Change Controls and performs/updates documents, as required, (i.e., specifications in accordance with test method changes, component changes, qualification of alternate sourced drug substances)
- Analyzes and interprets test results
- Operates general analytical instruments during raw material, IP and FP testing such as:
- High Pressure Liquid Chromatography (HPLC)
- Ultra Performance Liquid Chromatography (UPLC)
- Gas Chromatography (GC)
- Ultra Violet visible spectroscopy (UV/Vis)
- automatic titration
- Infra-Red Spectroscopy (IR)
- Thin Layer Chromatography (TLC)
- dissolution apparatus (Distek)
- Creates and uses custom fields in Empower software while operating HPLC/UPLC and GC instruments
- Collaborates closely with R&D for analytical method transfer studies and other analytical method related issues.
- Assists/performs identification and troubleshooting of problems with instrumentation, analytical anomalies, and laboratory investigations.
- Authors Residual Solvent, Elemental Impurity and Nitrosamine risk assessments
- Authors or updates SOPs, as needed
- Meets project deadlines and performance standards, as assigned
- Complies with all company policies and procedures, including safety rules and regulations
- Performs other related duties and responsibilities, on occasion, as assigned
Minimum qualifications:
- B.S. degree in Chemistry, or other related fields.
- 5 plus years job related experience in developing and validating analytical methods within the pharmaceutical or similar cGMP environment.
- Ability to maintain accurate records.
- Ability to apply existing work methods to different situations and solves problems ranging from recurring/routine to complex situations.
About us:
At Padagis our focus is on health care products that improve people’s lives. We are a market-leading generic prescription pharmaceutical company that specializes in “extended topical” medications, like creams, foams, mousses, gels, liquids and inhalable products. It’s a great time to join our team because we have a high growth trajectory with now more than 1,300 employees across six locations in the United States and Israel. We’ve already established a successful track record of launching first-to-file and first-to-market generic pharmaceutical products that have helped to make prescription products more affordable for patients and reduce costs for the healthcare system. Our team members work in a dynamic environment where opportunity is built on a foundation of honesty and transparency. Please consider joining our team where great things are happening and you can make a difference.
What’s Next:
At Padagis a real recruiter AND the hiring manager will review your application, not just a bot. This means we pay special attention to each application submitted for the position. While it could take a couple of days for us to get back with you, please know that we appreciate you applying for the open position and ask that you monitor your email for updates.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)