API Process Optimization Specialist

at  Novo Nordisk

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. It’s not your average production site – it’s a tight-knit, supportive community working together to contribute to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a patient-focused mindset guides everything we do. We’re looking for individuals who are self-starters with a strong work ethic to join our team. At Novo Nordisk, you will find opportunities, resources and mentorship to grow and build your career. Are you ready to realize your potential?

PHYSICAL REQUIREMENTS

0-10% overnight travel required. The ability to climb, balance, stand, walk, and finger. The ability to speak, listen, and understand verbal and written communication. Repetition including substantial movement of wrists, hands, and or fingers. Lifting up 33lbs/15kg of force occasionally, and/or up to 30 pounds of force frequently, and/or up to 10 pounds of force constantly to move objects. Visual acuity to determine the accuracy, neatness, and thoroughness of work assigned or to make general observations. The working environment includes a variety of physical conditions including: noise, inside and outside conditions including temperatures below 32 degrees f; close proximity to manufacturing equipment, moving parts, moving vehicles, and chemicals; atmospheric conditions including: odors, fumes, and dust. The ability to function in narrow hallways and spaces.

QUALIFICATIONS

• Education and Certifications:
• Master’s Degree (MS/MBA) or equivalent with a minimum of five (5) years’ experience or a Bachelor’s Degree in a technical discipline with a minimum of seven (7) years’ experience in an engineering or scientific discipline in a cGMP/ regulated pharmaceutical or biotechnology industry
• Work Experience:
• Minimum 2 years’ experience in a similar role
• Solid experience with project management, Lean tools/techniques, validation of API processes and regulatory submission documentation
• Knowledge, Skills, and Abilities:
• Must possess knowledge of large-scale protein production for commercial distribution, product quality attributes and API supply chain functions
• Knowledge of Pharmaceutical production technologies, production processes, unit operations and process characterization
• Leadership experience
• Excellent written and verbal communication skills
• Project management competency. (based on Project Management Body of Knowlegde (PMBOK))
• Ability to facilitate Steering Committee and Working group meetings in person or virtually
• Talent for networking and identifying groups/individuals with skillset to support project objectives
• Talent for negotiating workable resolutions to complex issues
• Must be comfortable communicating at all levels of the organization, including reporting to site leadership
• Must be comfortable conducting business in cross functional and multi-cultural environment
  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 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications

• Act as facilitator for Value Stream and Process Mapping activities for complex Biopharmaceutical production processes. Ensure team collaboration between a variety of stakeholders including Production, MSAT, Materials, Facilities, QC, QA and corresponding support groups in Denmark
• Participate in mid-range/ long range capacity and production planning with NNUSBPI Site Planner and Site Leadership
• Maintain and develop effective working relationships between NNUSBPI functions and support functions within DK. Facilitate meetings, track actions, drive results in all groups to ensure API process optimizations are planned and executed to support future capacity demands
• Facilitate communication and deliverables with HQ RA, regarding submitted files (BLA), variation applications and updates of regulatory documents as necessary to support process optimization efforts. This will include support to Q/A after submission and coordinate feedback to questions from the NNUSBPI organization to RA
• Establish and own project plans for activities related to API production optimization to ensure complex decisions can be made in a timely manner and key deliverables are on target according to plan
• Facilitate and maintain Quality Risk Management for API product lines
• Responsible for information and communication to internal (NNUSBPI) and external (DK, NJ, etc..) project stakeholders regarding projects, with specific focus on bottlenecks which present risk to product supply
• Ensure documentation and validation level of optimization projects is in accordance with NN and Regulatory authority guidelines
• Participate in cross-organisational activities within and outside BioPharm
• Participate in GMP and regulatory meetings within NN and external
• The position involves matrix project management of employees within the NNUSBPI operating functions and follow-up on qualification and validation status for optimization efforts
• Develop and maintain project budget in conjunction with NNUSBPI Finance partner
• Ensure persons with the right competences are allocated to the projects
• Close interaction with other functions within BioPharm
• Provide Support, through training, mentoring, and coaching to other staff members in project management or other specialty area of expertise