Commercial Quality Control Chemist II
Posted Updated
Serán is expanding its Bend, Oregon campus with a new GMP manufacturing facility and is seeking an industry-experienced Commercial Quality Control Chemist to play a critical role in the facility start-up of the new QC laboratory including equipment and facility qualifications. Once the facility is underway, The Commercial QC Chemist II supports the Quality Control laboratory’s ongoing commercial product testing activities in support of cGMP practices, product quality, regulatory compliance, and customer satisfaction. This position performs and provides technical expertise for commercial pharmaceutical testing, including finished facility testing, product release, stability, in-process control, raw material, and other analytical testing as assigned. The Commercial QC Chemist II serves as a technical resource for assigned analytical instrumentation, methods, and laboratory processes. The role supports analytical data integrity, laboratory investigations, method implementation, equipment qualification, and continuous improvement initiatives.
Supervisory Responsibilities
- May supervise QC laboratory staff continually or on a project basis.
- May assist with recruiting, interviewing, hiring, onboarding, and training new staff.
- May oversee the daily workflow, testing priorities, and execution of assigned commercial QC activities.
- May provide technical guidance, coaching, and support to QC Chemists I and other laboratory personnel.
- May assist QC management with workload planning, resource allocation, and meeting commercial testing timelines.
Duties & Responsibilities
- Perform routine and non-routine analytical testing of commercial pharmaceutical products, including facility testing, finished product release, stability, in-process control, raw material, and other QC testing as assigned.
- Demonstrate intermediate expertise with applicable analytical equipment and techniques, including HPLC, GC, dissolution, Karl Fischer, XRPD, mDSC, UV-vis, FTIR, and other laboratory technologies as qualified.
- Execute approved analytical methods, compendial procedures, and laboratory SOPs in accordance with cGMP requirements, specifications, and established testing timelines.
- Ensure analytical data, calculations, laboratory records, and supporting documentation comply with Good Documentation Practices (GDocP), data integrity principles, and applicable regulatory expectations.
- Technical Data Review: Perform technical review of analytical data, calculations, and supporting documentation for commercial testing, as assigned and within established qualification and authorization.
- Serve as a technical resource for laboratory investigations, including OOS, OOT, deviations, incidents, and unexpected analytical results, in collaboration with QC management and Quality Assurance.
- Assist with root cause analysis, corrective and preventive actions, and implementation of improvements resulting from laboratory investigations.
- Support the transfer, implementation, verification, and optimization of analytical methods for commercial products, as assigned.
- Assist QC management with daily laboratory workflow, testing priorities, resource coordination, and timely completion of commercial testing deliverables.
- Interface with clients and internal stakeholders on technical analytical matters, testing status, data inquiries, and laboratory concerns, as requested by QC management.
- Assist with the development, revision, and technical review of SOPs, specifications, protocols, reports, and other controlled documents.
- Support the training, mentoring, and qualification of QC laboratory personnel on analytical methods, instrumentation, procedures, and GMP practices.
- Maintain compliance with cGMP, GDocP, data integrity, laboratory safety, and applicable regulatory requirements while promoting a culture of quality and accountability.
- Identify and support opportunities to improve laboratory efficiency, testing accuracy, turnaround times, equipment utilization, and right-first-time execution.
- Assist with internal and external audits, regulatory inspections, and preparation of supporting laboratory documentation and records.
Required Skills & Abilities
- Demonstrates intermediate expertise with analytical equipment and techniques applicable to commercial pharmaceutical testing, including HPLC, GC, dissolution, Karl Fischer, XRPD, mDSC, UV-vis, FTIR, or other relevant technologies.
- Strong understanding of cGMP laboratory practices, Good Documentation Practices (GDocP), data integrity, and applicable regulatory expectations.
- Demonstrated ability to execute analytical methods and interpret analytical data accurately and effectively.
- Strong analytical, mathematical, troubleshooting, and problem-solving skills.
- Demonstrated ability to support OOS, OOT, deviation, and other laboratory investigations.
- Excellent verbal and written communication skills.
- Excellent interpersonal and customer service skills.
- Demonstrated ability to communicate effectively with coworkers, clients, and other internal and external stakeholders.
- Excellent organizational skills and attention to detail.
- Excellent time management skills with a proven ability to meet deadlines.
- Strong collaboration and cross-functional teamwork skills.
- Strong technical leadership and mentoring skills.
- Ability to prioritize tasks and coordinate laboratory activities as appropriate.
- Ability to function well in a fast-paced and, at times, stressful environment.
- Proficient with Microsoft Office Suite or related software.
- Familiarity with LIMS, electronic laboratory systems, Empower, or other applicable analytical data systems preferred.
- Accepts feedback from a variety of sources and constructively manages conflict.
- Demonstrated commitment to quality, compliance, safety, and continuous improvement.
Education & Experience
- Bachelor’s degree in Chemistry, Pharmaceutical Sciences, Biochemistry, or a related scientific discipline, with 2 years of hands-on laboratory experience preferred; or
- Master’s degree in Chemistry, Pharmaceutical Sciences, Biochemistry, or a related scientific discipline, with 1 year of hands-on laboratory experience preferred.
- Requires 1 year of GMP laboratory experience.
- Experience in pharmaceutical commercial QC testing preferred.
- Experience with applicable analytical instrumentation, laboratory investigations, and analytical method execution preferred.
Physical Requirements
- Prolonged periods of sitting or standing at a desk and working on a computer.
- Prolonged periods of standing or sitting while monitoring laboratory equipment.
- Must be able to lift up to 15 pounds at times.
- Adheres to consistent and predictable in-person attendance.
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Applicants must be authorized to work for an employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.
Benefits Summary:
Serán employees accrue over four weeks of paid time off annually. Employer contributions to a retirement account begin after 90 days and do not require an employee match or vesting period. Various health plans allow employees to find the best coverage for their individual or family needs with minimal employee contributions. Serán covers each employee with basic life and long-term disability, giving access to increase or add coverage. An Employee Assistance Program provides support for all things related to our employees’ wellbeing, along with access to pet insurance.
The Corporate Headquarters of Serán BioScience are located at 63047 Layton Ave, Bend, OR 97701
Skills
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Short answers (5)
- If someone from Serán initiated contact and referred you to this role, please type their name below optional
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- Have you ever worked for Serán BioScience before?
- Do you have experience in the pharmaceutical industry?
- Without providing dates of enrollment, can you confirm that you have completed the necessary education requirements of the position? optional
- Are you able to perform the essential functions of this job without reasonable accommodations? Note: We comply with the ADA and consider reasonable accommodation measures that may be necessary for qualified applicants/employees to perform essential job functions.
- As of this date, can you present evidence of your identity and legal right to work in this country?
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- Can you travel if the position requires it?
- Can you relocate if the position requires it?
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- I certify that all statements made in connection with this application (whether contained herein (and/or any supplements) or made by me or others at my request during the course of the employment process) are true and complete in al respects. I acknowledge and agree that any incorrect, incomplete, false, fraudulent, or misleading statements made by me, either verbally or in writing, and/or any omission, concealment, or failure or answer any question fully, completely, and accurately, whether made by me or others at my request, will result in rejection of this application, denial of employment, or termination from employment if discovered after employment.
- I authorize the investigation of all matters which Serán deems relevant to my qualifications for employment, including, without limitation, work records, reference checks, education, and an investigation into my driving record. I authorize and request that all my present and former employers, references, educational institutions, and any others to furnish and release information about me, my employment record, and/or education, including a statement of reason for the termination of my employment and information regarding my work performance, disciplinary reports or actions, abilities, degrees obtained, transcripts, licenses and certifications, and other qualities and information Serán deems pertinent to my qualifications for employment. I release Serán (and all providers of information) from all claims and/or liabilities arising out of or in any way connected with Serán's background investigation. If employed, I release Serán from any claims and/or liabilites for future references it may provide regarding my work history and performance with Serán.
- I understand that if offered employment, I will be required to submit proof of my identity and legal right to work in the United States as a condition of employment.
- I understand that any job offer may be contingent on me successfully passing a criminal background check/investigation. I release Serán from all claims and/or liabilities resulting from or related to the criminal background check/investigation.
- I understand that any job offer may be contingent on me successfully passing a pre-employment drug screen. I agree to hold harmless and release Serán and its agents from all claims and/or liabilities resulting in whole or part out of the collection of specimens, testing and the appropriate use of the information from such testing.
- I understand that, if employed, my employment relationship with Serán will be at-will. Therefore, subject to applicable law, my employment may be terminated (and I may voluntarily resign) at any time, for any reason or no reason, with or without cause or prior notice. Nothing contained in this application, or provided in connection herewith, will be construed as an offer or promise of employment, nor does this application create any employment contract or guarantee that employment or any benefit will be provided or continued for any period of time.
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