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Senior Manager of Metrology at

Senior Manager of Metrology

Andover, MA (Onsite) Full-Time

Senior Manager of Metrology

 

About Oncorus:

Oncorus is a biopharmaceutical company located in Andover, MA, focused on developing next-generation, systemically active viral immunotherapies to transform outcomes for cancer patients. At Oncorus, our mission is to enable more patients to respond to this revolutionary approach of harnessing the body’s immune system to tackle cancer. We are advancing a pipeline of intravenously administered product candidates for multiple indications with significant unmet need based on our selectively self-amplifying viral RNA (vRNA) Platform. Our viral immunotherapies are designed to selectively attack and kill tumor cells to stimulate multiple arms of the immune system against tumors. Please visit to learn more.


Summary:

Based at our newly constructed Andover, MA GMP manufacturing site, the Senior Manager of Metrology reports to the Vice President of CMC Operations and is responsible for the calibration and maintenance of all GMP/non-GMP process, laboratory, and support equipment and instrumentation at Oncorus.  In addition, this individual is the system owner and subject matter expert for the equipment management electronic system.  The individual in this role requires excellent communication and organizational skills, as well as a focus on operational excellence and process optimization. As we scale, this individual is expected to lead people and projects, often cross-functionally, and may have direct reports in the future. This individual must demonstrate an independent drive and collaborative spirit to operate in our dynamic, fast-paced environment.

 

Essential Duties and Responsibilities:

  • Receive, qualify, and maintain manufacturing and process development equipment.
  • Support equipment commissioning/validation, process transfer, and troubleshooting.
  • Performing and coordinating calibration / metrology work to ensure that instrumentation is calibrated properly and on schedule to comply with good calibration / metrology guidelines.
  • Follow current good manufacturing practices, write standard operating procedures, and maintain laboratory standards.
  • Hands-on calibration and maintenance, troubleshooting, calibration and repair, on a variety of complex analytical instrumentation for laboratory or calibration / metrology applications.
  • Able to identify and manage multiple outside vendors performing calibrations on various types of equipment.
  • Working closely with department management to stay informed on all department activities.
  • Provide overall technical leadership for the calibration program by overseeing and driving the day-to-day calibration related activities, preventive maintenance, and documentation for laboratory equipment.
  • Prioritize, schedule, and implement calibration plans and timelines for equipment to support development and manufacturing needs of site equipment.
  • Execute equipment qualification protocols and procedures to ensure equipment qualifications meet appropriate domestic and international regulatory agency requirements.
  • Support equipment commissioning/validation, process transfer, and troubleshooting.
  • Maintain cGMP records, both paper-based and electronic.

 

Qualifications:

  • Bachelor’s degree in Engineering, Metrology, Chemistry, or Biology with 7+ years relevant experience or Master’s degree in Engineering Metrology, Chemistry, or Biology with 10+ years of relevant experience or an Associate’s Degree in Metrology w/ 15+ years’ experience
  • Demonstrated knowledge of GMP and experience in a regulated GMP manufacturing environment.
  • Experience in maintaining and operating CMMS systems in a GMP environment preferred.
  • Experience owning and provide supporting CAPA’s, Change Controls, and Deviations required.
  • Familiarity with calibration of systems/equipment such as TFF skids, Chromatography Columns and skids, mixers, vessels, Controlled Temperature Units
  • Proven management experience a plus
  • Ability to work independently w/ minimal supervision.
  • Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
  • Excellent critical thinking abilities plus exceptional verbal and written communication skills.
  • Technical writing skills required.

  • Must be able to work in a controlled or clean room environment requiring special gowning.
  • Must have the ability to work safely and conscientiously in a manufacturing environment.
  • As production gets underway, some weekends or holiday work may be required.

 

The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Oncorus is an EEO employer committed to an exciting, diverse, and enriching work environment. We recruit and employ individuals without regard to race, color, religion, creed, national origin, age, gender, sex, sexual orientation, gender identity, marital status, military or veteran status, disability, genetic information, or any other category protected by applicable federal, state or local law. The company may provide reasonable accommodations to employees on the basis of disability or religion, as required by law.

Full vaccination against COVID-19 is a requirement and essential function of this position. The Company conducts background/reference checks and confirmation of vaccination for COVID-19 as part of its employment process and any offer of employment is contingent upon satisfactory completion of the foregoing checks and confirmation.

Applicants must be authorized to work for any employer in the US. We are unable to sponsor or take over sponsorship of employment Visa at this time.

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