Process Professional II - API manufacturing

Initial Therapeutics, Inc.; Petersburg (VA); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Leading pay

Annual performance bonus

Paid time off: 14 holidays

Health/Dental/Vision insurance – day 1

401K with company match

Parental & family leave

Tuition assistance

Life & disability insurance

Employee referrals

Job summary

Novo Nordisk in Petersburg, VA is seeking a Site Subject Matter Expert (SME) for the Operations department. You will provide GMP knowledge, lead strategic projects, and coach Process Professionals to meet cost, quality, and schedule targets.

You will investigate deviations, drive lean improvements, manage master data, and report progress to Senior Management, while collaborating with stakeholders across NN sites and ensuring safety compliance.

Qualifications

• Bachelor’s degree in an engineering/technology related field is required, plus manufacturing experience.
• LEAN manufacturing experience and training are required.
• General knowledge of change control systems and Quality Management Systems (QMS) is required.
• Relevant electronic manufacturing system experience (e.g., SAP, PAS-X) is required.
• Experience with regulatory audits/inspections is expected.
• Product transfer/tech transfer experience is a plus.

Responsibilities

• Support senior leadership as part of the department management group through strategic discussions and decision making.
• Provide in-depth deviation investigations and root cause analysis.
• Drive continuous improvements via Lean tools and Six Sigma methodologies and certifications.
• Maintain area content and process knowledge; manage master data and recipes.
• Collaborate across sites and report project status to Senior Management.
• Follow safety and environmental requirements in performance of duties.

Skills

LEAN manufacturing

Root cause analysis

GMP knowledge

Coaching/mentoring

Stakeholder communication

Problem solving

Education

Bachelor’s degree (engineering/technology/related)

Associate’s degree + 5 years manufacturing

High School Diploma + 7 years manufacturing

Tools

SAP

PAS-X

QMS software

Job description

About the Department

For more than 100 years, Novo Nordisk has been tackling the unmet medical needs of people living with serious chronic diseases, such as diabetes & obesity. Being part of Novo Nordisk allows our employees to embark on the opportunity to help improve the quality of life for millions of people around the world.

Our new Petersburg, Virginia site marks a strategic move to advance our capabilities in Emerging Technologies (ET) within Chemical API development and production. The highly experienced site is designed to strengthen and accelerate our Small Molecule (SMOL) strategy while amplifying our operational capacity. This is to safeguard and support ET´s SMOL projects in the coming years, aligning with our vision and strengthening our potential for growth and innovation.

What we offer you:

• Leading pay and annual performance bonus for all positions
• All employees enjoy generous paid time off including 14 paid holidays
• Health Insurance, Dental Insurance, Vision Insurance – effective day one
• Guaranteed 8% 401K contribution plus individual company match option
• Family Focused Benefits including 14weeks paid parental & 6 weeks paid family medical leave
• Free access to Novo Nordisk-marketed pharmaceutical products
• Tuition Assistance
• Life & Disability Insurance
• Employee Referral Awards

At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career. Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters.

The Position

Provide GMP knowledge and strategic support to the organization as the Site Subject Matter Expert (SME) for the Operations department. Lead and support various projects as required based on evolving business needs as it relates to GMP and quality within the operations department. Act as a coach/mentor to area Process Professionals. Communicate on behalf of Novo Nordisk with stakeholders related to projects and production. Complete assigned projects and project tasks within cost, quality and schedule requirements. Present project status updates to Senior Management.

Relationships

Reports to Manager/Director. The role is responsible for collaborating with stakeholders related to assigned area as well as other stakeholders across the site and other NN sites.

Essential Functions

• Support senior leadership as part of the department management group through participating in strategic discussions and decision making
• Responsible for providing in-depth deviation investigations and root cause analysis
• Drive continuous improvements via Lean tools and Six Sigma methodologies and certifications
• Responsible for area content and process knowledge
• Identify and implement process needs and improvement opportunities for moderate to high complexity issues
• Responsible for periodic reviews and reporting.
• Involved with collaboration across sites
• Update and manage area master data and recipes as needed
• Provide support on defined issues and contributes through application of expertise and knowledge
• Follow all safety & environmental requirements in the performance of duties
• Other duties as assigned

Physical Requirements

Ability to work in an open office environment with the possibility of frequent distraction. Ability to travel up to 20% of the time (% can change on a case by case basis based on the role).

Qualifications

• Bachelor’s degree (engineering, technology or related field of study preferred) from an accredited university required and a minimum of three (3) years of manufacturing experience required, preferably in a pharmaceutical manufacturing environment
• In lieu of Bachelor’s degree plus three (3) years of experience, may consider an Associate’s degree (engineering, technology or related field of study preferred) in technology or related field of study from an accredited college or university with a minimum of five (5) years of manufacturing experience required
• In lieu of Bachelor’s degree plus three (3) years of experience, may consider a High School Diploma or equivalent with a minimum of seven (7) years of manufacturing experience required. Excellent written communication skills required
• Thorough investigation and systematic problem-solving experience required
• LEAN manufacturing experience and training required
• General knowledge of change control systems and Quality Management Systems (QMS) required
• Relevant electronic manufacturing system experience required (ex: SAP, PAS-X, etc.)
• Demonstrated knowledge of adult learning methodologies and ability to use multiple methods to train and coach others preferred
• General experience with regulatory audits/inspections required
• Knowledge of relevant master data preferred
• Validation experience preferred
• Product transfer (or tech transfer) experience a plus

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

At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.

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.