Job Description

The RTP General Manager and VP of Manufacturing is accountable for concurrent clinical and commercial multi-modality manufacturing operations located at Biogen’s campus located in North Carolina.  Responsibilities include multi-scale Drug Substance protein manufacturing plants (15K scale facility, 2K scale facility and a 1K flexible disposable technology facility), a Drug Product facility and an Oligonucleotide facility.  Operational responsibilities also include all support infrastructure including Central Utility Buildings and Warehousing Operations. 

The leader is responsible for all site operational activities through solid and matrix organizational lines including; but not limited to, safety and environmental sustainability, business continuity, talent management/succession planning and engagement/retention strategies.  The incumbent leads the cross-functional site leadership team (SLT) to assess critical decisions, evaluate complex site operational issues and identify resolution strategies required to optimize throughput and output to advance operational objectives. The incumbent also: identifies and implements policies, procedures and business strategies to facilitate optimal operations; drives internal processes including risk assessment, strategic planning, and management of internal/cross-functional/cross-site alignment; leverages best practices and advances operational excellence to optimize operations;  provides overall leadership of site manufacturing operations and ensures alignment with Global Manufacturing strategies, policies and practices.   The incumbent provides operational direction for up to six (6) direct reports including up to seven (7) dotted line reporting relationships and leads an organization of up to 600 FTEs.

As General Manager, the leader also serves as the site head and liaison to the local community.  Site Quality, Engineering, Environmental Health and Safety, Manufacturing Science, Finance, Human Resources and Information Technology.  This position is also heavily involved in external government affairs and political governance forums to advance site infrastructure and operational capability robustness and is a member of local boards serving the Biotech industry.  Furthermore, the General Manager collaborates, influences and supports critical negotiations and ongoing relationship management across various external strategic partners.  The General Manager chairs the cross- site senior leadership team and collaborates closely with their HR Business Partner and other cross-functional entities to advance operational/Corporate/community strategic goals.

This leader will report to SVP, Global Manufacturing and Technical Operations, and will be based in RTP, NC. 

MAIN RESPONSIBILITIES  

The VP Manufacturing/General Manager sets strategic direction for the site, in alignment with Global Manufacturing and Corporate and Pharmaceutical Operations and Technology (PO&T) strategic goals and objectives.  This leader is expected to set a culture of collaboration and alignment between Manufacturing, EHS, Quality, Engineering, Technical Development and other site service functions, to ensure that these major strategic objectives are met.  This person ensures the site operations and associated facilities meet cGMP requirements and that compliance with global regulatory standards is sustained.  This person must work collaboratively with leaders across the network and supply chain to ensure seamless end to end integration of clinical and commercial products.  Furthermore, this individual must partner closely with the development team, from an early stage, to stay abreast of new technology development and offer input on a frequent and consistent basis, and successfully implement new technology solutions.

• Oversees all site operational activities in a safe and reliable manner.  This includes leading teams to resolving operational, manufacturing and facility issues to ensure minimal costs and prevention of operational delays; conferring with department heads on all critical decisions, identification of issues and problem resolution to ensure concurrence and adverse operational impact.  Manages and influences operational advancements and synergies with multi cross-functional groups.
• Develops strategic site direction and leads teams in development of associated tactical plans.  Directs and coordinates all activities to develop and implement long-range goals and objectives to meet business and profitability growth objectives. Ensures synergy between the long-range financial plan (LRP), Global Manufacturing strategic operating strategy; Establishes short and long-term manufacturing goals, objectives and strategies ensuring that appropriate policies and procedures are in place to accurately measure, monitor and report actual versus planned results; Identifies, designs, implements and measures programs to improve operational performance.  Responsible for preparation, review and approval of operating budget and COGM including identification of critical improvements and opportunities to reduce COGM and operating expense while increasing site capabilities, efficiencies and overall productivity.
• Supports Corporate/Local business development activities and develops relationships with key local countries.
• Business Alliance Leadership.  Responsible for developing and managing external alliances for site.  Collaborate with organizational leaders to ensure Partner programs are functioning in a safe and reliable manner, including resolving any operational, manufacturing and facility issues to ensure minimal costs and prevention of operational delays.
• Talent Management and Development.  Responsible for RTP Manufacturing talent management/succession planning actions and operational employee engagement/retention strategy. Building, managing and retaining an A player team.

Qualifications

The ideal candidate will be an established leader in this space and will have led and motivated teams.

Professional Qualifications 

• Demonstrated success in managing, motivating and continually strengthening a large, complex and multi-disciplinary organization.
• Minimum of 20 years of experience in a biopharmaceutical / pharmaceutical operations or related industry environment.
• Practical knowledge and application of cGMP and cGLP compliance regulations and inspections plus experience interfacing with inspectors, investigators and/or agency personnel on the district and national scale.
•  Demonstrated capabilities in transforming and modernizing a sizable operation by appropriately leveraging standards and technology and end to end thinking.
• Ability to build, convincingly communicate and execute strategic and operational plans for a global manufacturing function.
• Exceptional interpersonal skills including the ability to influence behaviors and negotiate and resolve challenges with poise, tact and diplomacy.
• Exceptional leadership skills, with the ability to communication vision, set direction, as well as inspire, motivate and mentor a cross functional team.
• Exceptional oral and written communication skills to all employment levels and to executive leadership teams.
• Demonstrated knowledge and understanding of regulatory principals and requirements as applied to biologically derived therapeutics.
• Proficient at understanding and analyzing financial reports and overall business acumen
• Demonstrated ability to analyze, extrapolate data, hypothesize, plan and implement

Personal Characteristics 

• A proven ability to operate effectively in a rapidly changing environment where analytical skills and agility are equally as important; a strategic thinker who is operationally focused who can manage diverse agendas and personalities
• Self-aware, self-motivated, self-confident individual who is comfortable operating with minimal direction and who thrives in a dynamic environment as a leader influencing change and transformation. 
• Credible and savvy business person who is well networked across industry and will be perceived as a trusted consultant and functional expert to senior management.  Must be an influential advisor; bold and courageous while having the antennae to understand cultural and political nuance
• Knowledgeable in leading edge security business practices, trends and information; aware of strategies and tactics being applied in the marketplace that are innovative
• Able to engender trust and respect quickly as a manager of people, with a priority for the development of staff.  A capability builder at both the organizational level as well as the individual level
• An individual of unquestioned personal and business integrity who will be viewed as trustworthy both within the company, as well as with external relations
• Mission-driven individual with high energy and high levels of perseverance; works towards both individual and team goals

EDUCATION

B.S. or Master’s degree in Biochemical or Chemical Engineering or related scientific field.  PhD preferred.

Additional Information

All your information will be kept confidential according to EEO guidelines.