Job Description

Senior Specialist, Operations

Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a "Safety First, Quality Always" mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products.

We have an exciting opportunity for a Senior Specialist to join the operations team for a capital project start-up in Durham, North Carolina. The facility includes end-to-end processing of drug substance, drug product, including biotech culture growth, harvest, lyophilization, product inspection, and quality control laboratories. This position requires the ability to work independently with moderate to minimal supervision, produce/complete various assignments requiring analytical ability, demonstrate independent judgment, creativity and problem-solving skills. This role also requires strong collaboration and communication skills to enable interfacing with both internal contacts (local site level) and external contacts (external customers, above site partners, vendors) to support these initiatives. The Senior Specialist must be able to work efficiently in a fast-paced environment and be hands-on when called for by the situation.

This is a full-time position working Monday through Friday, dayshift (normally 8:00am-4:30pm).

Applicant must complete and be medically cleared for BCG medical clearance requirements: questionnaire, blood test, chest x-ray.

Position Description:

The duties of Senior Specialist, Operations include but are not limited to:

• Lead production schedule across operations (e.g. media, drug substance, drug product, etc.). Interface with site planning and other IPT scheduling teams
• Assist with facilitation of Project and site Tier meetings and help manage the operations project portfolio.
• Guide cross-functional teams to advance project goals.
• Manage area metrics/KPIs/schedule
• Assist in developing operations controls and metrics to display the overall health of the project.
• Develop and implement plans in partnership with other internal departments and above site and external contacts on different projects and initiatives.
• Communication skills must be effective to interact with internal/external customers to manage projects, assignments, and workflow.
• The successful candidate should be able to examine an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) to best comprehend and resolve it at the root cause.

Key Competencies:

• Critical thinking, problem solving and decision-making skills
• Ability to see big picture and identify improvements aligned with business objectives.
• Comprehension of program and project management fundamentals including indirect management skills.
• Prioritization, planning, organizing and delegation skills.
• Working with peers, management and both internal and external partners.
• Conflict management
• Customer-focused
• Self-directed
• Communication with diverse audiences
• Strategic end to end thinking

Education Qualifications:

• Bachelor's degree in an Engineering or Science related field with at least five (5) years of experience in manufacturing/operations in a regulated industry OR
• Master's degree in an Engineering or Science related field with at least four (4) years of experience in manufacturing/operations in a regulated industry

Required Experience:

• Experience with Project Management and/or indirect leadership.

Preferred Qualifications:

• Experience working in a pharmaceutical, biotech or vaccines manufacturing environment
• Scheduling experience
• Lean Six Sigma Green Belt or Black Belt Certification
• Experience with aseptic processing operations such as cell culture, filling, and/or lyophilization
• Experience authoring technical documents such as Standard Operating Procedures (SOPs) and change requests within a current Good Manufacturing Practices (cGMP) context

The salary range for this role is $94,300.00 - $148,500.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available.

You can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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