Sr QC Chemist – Raw Materials API Job
At Novo Nordisk, we want to make a difference. For more than 90 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on life-changing careers, and the opportunity to help and improve the quality of life for millions of people around the world.
To help meet the growing demand for our diabetes treatment, Novo Nordisk expects to double production of diabetes drugs over the next decade. Novo Nordisk is currently building a new diabetes API plant in Clayton, NC next to our existing facility that employs 800 people. The new plant will initially employ 700 employees to produce the active ingredients for a new diabetes oral treatment and a range of other diabetes drugs.
Novo Nordisk is currently seeking top talent for this green field project and eventual operations. This once in a life-time career opportunity is ideal for manufacturing professionals who not only understand the operational complexities of manufacturing but also have the desire and drive to help us design and build. Here you will work with the best manufacturing professionals in the industry, while learning and taking part in the plant design.
Additional Information Position Purpose: Plan, manage & perform laboratory method validation activities. Routine review of laboratory validation procedures & completed validation protocols for accuracy, completeness & maintain validated state per corporate requirements. Gather & ensure knowledge transfer & alignment on all QC Raw Material practices & procedures between Denmark & DAPI US (travel to Denmark is required) ensuring coordination & collaboration with all relevant stakeholders.
Accountabilities:
* Method Validation & Testing process SME for QC Raw Materials.
* Document preparations including SOPs, method validation protocols/reports & calibration.
* Accuracy & scientific soundness of lab data.
* GMP compliance of lab.
* Environmental compliance.
* Timeliness of lab results.
* Instrument qualification.
* Perform non-conformity & change control activities.
* Other duties as assigned.
Education: Mandatory
BS/BA in life sciences, chemistry, engineering, or a relevant combination of education & experience.
Experience: Mandatory
5+ years of chemistry, laboratory validation, or engineering experience in the pharmaceutical industry or related field.
5+ years of laboratory method validation experience.
Experience writing & executing validation protocols.
Technical/Process/Functional Knowledge:
* Extensive knowledge of GMPs, ICH guidelines & Pharmacopeia (USP/NF & Ph. Eur.) methods.
* Strong communication skills (verbal & written).
* Able to perform GC, HPLC, AAS, FTIR, NIR, UV-Vis analysis & troubleshooting for laboratory equipment.
* Experience with validation of QC Instruments, Equipment Utilities & USP <1058>.
* Experience with validation of QC methods & method transfer.
* Demonstrated ability to write technical & scientific documents & reports.
* Demonstrated ability to present technical & scientific information to others.
Organization/Planning:
Demonstrated ability to manage multiple project & competing priorities.
Physical & Other Requirements:
* Ability to work in & around an active construction site.
* Able to work with hazardous materials & chemicals.
* Corrected vision to 20/30.
* Able to lift 25 pounds with assistance.
EEO Statement:
Novo Nordisk is an Equal Opportunity Employer – M/F/Veteran/Disability/Sexual Orientation/Gender Identity.
Novo Nordisk is not currently hiring individuals for this position who now or in the future would require sponsorship for employment visa status.
Department DAPI US – QC Raw Material
Position Location US – Clayton, NC
City Clayton
State/Provinces US – NC
Job/Position Country US
At Novo Nordisk, we know that driving change on a global level and improving treatment outcomes for people with diabetes and other chronic diseases begins here at home. That's why we make an unmatched commitment to our employees, our families and our communities. That means outstanding rewards, industry-leading training programs, and an environment that supports you to achieve your goals at every level. It's all part of the Novo Nordisk Way. It includes our Vision and our commitment to the Triple Bottom Line principle – helping us find the right balance between compassion and competitiveness
With a career at Novo Nordisk, you’ll feel a difference right from the start. It’s a sense of inspiration and mobility that comes from a shared belief in driving positive change for people, families, and communities everywhere. Congratulations on taking your first step!
Novo Nordisk is committed to equal employment opportunity and providing reasonable accommodations to applicants with physical and/or mental disabilities. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, gender, sex, age, religion, creed, national origin, ancestry, citizenship, marital status, physical or mental disability, medical condition, veteran status, genetic information, or any other characteristic protected by federal, state, or local law.
Novo Nordisk 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…cont.
