Description:

REMOTE - any location OK. Can work respective hours in their time zone, but must have some flexibility for occasional meetings outside of regular business hours.

• External Supply Operations is seeking a Strategic Planning & Operations Manager to support the Portfolio Strategy & Execution (PSE) team.

 

• This role will support the External Supply Operations organization by leading NPIs and coordinating product transfers into the external manufacturing network, as well as advancing systems and processes related to Site Selections, Launches, and Technical Transfer Management.
• This person will lead efforts that focus on joint team engagements, identifying and delivering on key project milestones, integrate external supplier functions with company processes, provide recommendations to drive pivotal initiatives, business performance and operational improvements. 
• The Manager is responsible to stay informed of standard methodologies and provide innovative, impactful ideas to optimize processes to support the organization’s growth strategies.
• The successful candidate will lead multiple NPIs, projects and initiatives that advance External Supply Operations strategies, goals and objectives. 

Specific responsibilities include:

• Responsible for leading new product introduction activities for new launches or programs tech transferring into CMOs
• Provide project strategic direction of external manufacturing technical transfer and new product introduction activities coordinating execution of cross-functional
• workstreams from Quality, Process Development, Contracts, Supply Chain, Analytical Sciences and Global Strategic Sourcing.
• Execution and adherence to PSM NPI business processes and operating model
• Strong interpersonal skills as interactions will be both internal and external facing with CMOs and Executive leadership.
• Lead multiple cross-functional projects of medium to high complexity.
• Build and maintain project plans and team assignments using project planning tools, estimating project cost and adhering to budget, directing and supervising work efforts on daily basis, identifying resource needs, performing project reviews, and advancing functional, quality, timeline and cost issues appropriately.
• Understand and react to project risks, scope changes, industry trends and influences.
• Utilize project management processes, software and methodologies to ensure projects are delivered on time, within budget, adhere to high quality standards and
• meet customer expectations.
• Handle communication with all areas of the enterprise that impact scope, budget, risk and resources of the work being managed and provide project updates and reporting to executive leadership and internal partners.
• Lead continuous improvement projects that deliver measurable gain in quality, efficiency and alignment within priorities. Apply the knowledge, skills, tools of
• project management and operational perfection to ensure efficient execution of projects and continuous improvement initiatives.

Basic Qualifications:
Doctorate degree OR Master’s degree and 2 years of solid experience within a cGMP manufacturing or quality environment OR Bachelor’s degree and 4 years of solid
experience within a cGMP manufacturing or quality environment OR Associate’s degree and 10 years of solid experience within a cGMP manufacturing or quality
environment OR High school diploma / GED and 12 years of solid experience within a cGMP manufacturing or quality environment

Preferred Qualifications:

• Strong organizational and cross-functional project management skills
• Strong technical background with understanding of pharmaceutical manufacture and commercialization
• High ethical business standards, fosters inclusivity and promotes diversity
• Demonstrated accountability to deliver results and meet deadlines while handling contending priorities
• Problem-solving, critical thinking and decision-making skills
• Strong interpersonal, listening and customer service skills
• Strong presentation abilities, oral and written, including confidence and decisiveness when engaging with Senior Management and customers
• Experience managing and influencing in a matrix organization
• Manufacturing and cGMP knowledge and experience
• Strong negotiation skills
• Operational Excellence proficiency
• Understanding of contractual requirements
• Technical writing and multi-level presentation skills
• Experience leading effectively in collaborative team environment
• Ability to take initiative, drive action and work under minimum supervision
• Proficiency in Microsoft Office especially Project, Excel, PowerPoint, Visio, Smartsheet and ThinkCell

Top 3 Must Have Skill Sets:    

• Project Management Experience 5 years minimum
• Pharmaceutical manufacturing or operations experience, benefit if they have worked with pharmaceutical contract manufacturing
• Degree in science field - (Chemistry, Chemical Engineering, Biochemistry, Microbiology)

Nice to have: Process Engineering background

Pay Rate  between $67 - $77hr on W2 based on experience.
 
"This posting is for Contingent Worker, not an FTE