Batch Release Coordinator - Biotech Manufacturing

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Job description

About the Department

Site New Hampshire, located in West Lebanon, is where Novo Nordisk's life-saving treatments are brought to life. Our manufacturing facility produces a global supply of our hemophilia and growth hormone product lines, as well as our next generation of cutting-edge medications.

What we offer you:

• Leading pay and annual performance bonus for all positions
• 36 Paid days off including vacation, sick days & company holidays
• Health Insurance, Dental Insurance, Vision Insurance
• Guaranteed 8% 401K contribution plus individual company match option
• 12 weeks Paid Parental Leave
• Free access to Novo Nordisk-marketed pharmaceutical products

At Novo Nordisk, you will find opportunities, resources and mentorship to grow and build your career. Are you ready to realize your potential?

The Position

Contribute to the delivery of Active Pharmaceutical Ingredients (API) as agreed to in the site production & capacity agreements. Support the release of API by helping ensure the timeliness of release at continuously improving quality & cost. Ability to communicate release needs throughout the organization. Act as a project coordinator to ensure that all activities related to the release of a particular batch is coordinated with all stakeholders & contributing organizations, & all activities are performed in the most efficient & timely manner

Relationships

Reports to: Manager, Supply Chain

Number of subordinates with direct/indirect referral: none

Essential Functions

• Perform activities to support Batch Release
• Coordinate with Supply Chain Planning to ensure that the agreed amount of API can be released in accordance with release & lead-time targets
• Responsible for maintaining and running Release performance board
• Manage applicable batch release checklists using Styx
• Verify the completion of required batch documentation & document on the applicable checklist
• Request status assignment for Drug Substance (K6)
• Verify potency has been calculated & entered into SAP by production
• Facilitate batch release activities
• Collect batch documentation in systems to include SAP, LIMS, & MES & update data as required
• Monitor status of batch status inputs as follows & communicate obstacles on timely progress:
• Open Deviations with impact on release
• Change Requests blocking release
• Batch-related LIMS results o Release of Formulation batches/Production support batches

Timely review of monthly critical logs o Water/Clean steam release reports to cover release period

Batch documentation approval

Batch potency SAP entry

Yield documentation o EM sampling following area release

Cleaning Verification reports

Ensure release documentation follows all applicable corporate & local SOPs

Provide guidance to stakeholders regarding batch release & related activities

Support systematic problem solving & participate / review cross-functional investigations

Participate in process confirmations & "Go Look See"

Participate in knowledge & experience sharing to assure collaboration, communication & creating results in relation to compliance with company procedures, policies & objectives

Develop reporting tools & key process indicators within the batch release area

Evaluate, trend & report data for continuous improvement in the release process

Performs all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable healthcare laws, regulations, and industry codes

Incorporates the Novo Nordisk Way and 10 Essentials in all activities and interactions with others

Other duties as assigned

Qualifications

• Education and Certifications
  • Bachelor's Degree in Life Sciences, Engineering, Supply Chain Management, or related field required.
• Work Experience
  • Minimum three (3) years of experience in supply chain, quality, project management or related field preferred. Previous experience & general knowledge in cGMP manufacturing & production processes preferred.
• Knowledge, Skills, and Abilities
  • General knowledge in Batch Release Processes as related to pharmaceutical or cGMP production processes a plus. Project management experience working with cross-functional teams a plus. Excellent written & verbal communication skills required. Excellent computer skills in MS Office, PowerPoint, Word, Excel, etc required. Application of cGMPs in pharmaceutical manufacturing preferred. Knowledge of SAP systems (BW, APO, ECC, SAP4HANAH, OMP) or similar ERP / material management systems preferred. Proven Process Improvement & problem-solving skills preferred. Experience in the use of Six Sigma & LEAN tools a plus. Organization/Planning: Ability to develop, manage & achieve action plans; good negotiation, communication & collaboration skills required.

Physical Requirements

0-10% overnight travel required. The ability to climb. Stoop, kneel, crouch, reach, and walk. The ability to pull, lift, finger, and grasp. The ability to speak, listen, and understand verbal and written communication. Repetition including substantial movement of wrists, hands, and or fingers. While performing this job employee work involves sitting most of the time with walking and standing required only occasionally. This position may lift up to 20 pounds occasionally and 10 pounds frequently to lift, carry, push, pull or otherwise move objects. Visual acuity to perform close activities such as: reading, writing, and analyzing; and to determine the accuracy, neatness, and thoroughness of work assigned or to make general observations. The working environment includes a variety of physical conditions, working in narrow aisles, and temperature changes.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we're life changing.

Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.

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