Sr. Manager, Smart Commercialization Team

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI.

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

Summary of Objective:

The Sr. Manager, Smart Commercialization Team supports PCI Pharma Services by coordinating all end-to-end activities required to move a drug from late-stage clinical development through initial commercialization shipments. This position fully integrates with the customer working with both sponsor and vendors to ensure all commercialization activities are completed on time. The role requires the Sr. Manager to draw from previous commercialization experience to guide the sponsor thorough the entire commercialization process by consulting or, when necessary, leading to ensure product launch occurs within the established timeline.

Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities are the following but other duties may be assigned.

• Leads all supply chain launch activities needed from final clinical development through commercial launch.
• Provides consultative support to the Sponsor to provide the optimal route for commercialization.
• Performs project management activities such as creating and maintaining timelines; creating and monitoring KPIs for the business, new market entry, and product launches; and coordinating activities and deadlines across functional units to ensure commercial launch happens on time.
• Implements and/or supports clients' supplier relationship management (SRM) business practices.
• Leads and actively manage relationships with key stakeholders within PCI, the Sponsor, and any additional vendors needed to perform commercialization activities.
• Organizes activities to ensure on-time and in-full production and confirmed order shipments.
• Supports the Sales and Operations Planning process across commercial programs.
• Works closely with customers' Commercial Operations and Regulatory Affairs to actively manage label and secondary package design operations including development, proof review/approval, and communication to printed component suppliers.
• Collaborates with customers' team to ensure drug substance and drug product availability and Commercial Operations team to provide forecast data for inventory maintenance.
• Supports clients' regulatory filings by providing input and data such as critical process parameters (CPPs), container closure design master files (DMFs), and component specifications.
• Collaborate with Business Development to ensure that customer commercial demand is aligned with manufacturing capabilities while alleviating resource constraints across the clients' entire product portfolio.
• Participate in the development of target product profiles and ensure alignment across the (Tech Ops) organization.
• Ensure new product introduction plans incorporate multiple launch scenarios and account for any potential changes in strategy.
• Ensure that all pre- and post-launch operational activities are planned and communicated.
• Developing a deep understanding of current and future external supply needs and clearly link supplier utilization to the overall strategy.
• Partner with client forecasting to identify demand assumptions such as sales forecasts and launch planning to develop supply requirements plans.
• Lead business operation launches activities including managing submission business and technical agreements through internal approval process.
• Analyze data to make decisions on printed component supplier selection, adjustments to component inventory holding levels, and other critical operational decisions.
• Assess timeline impacts of any quality and manufacturing issues and work with Quality and Manufacturing teams to facilitate collaborative reviews of deviation investigations.

Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

Required

• Bachelor's degree in a related field and 5+ years of experience developing and commercializing drugs.
• Experience launching a commercial product
• College Level Mathematical Skills
• Intermediate Computer Skills: Ability to perform more complex computer tasks and has knowledge of various computer programs.
• Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
• Very High Reasoning: Ability to define problems, collect data, establish facts, and draw valid conclusions. Be able to interpret an extensive variety of technical instructions in math or diagram form and deal with several abstract/concrete variables.
• Ability to Travel (up to 25%)
• Knowledge of and adherence to GMP requirements as well as PCI policies, procedures, and rules.
• Able to thoroughly and succinctly present the commercialization capabilities of PCI both internally and externally to prospective customers.

Preferred

• Knowledge of the requirements to commercialize a variety of dosage forms.
• Previous experience in management positions.
• Previous experience with PCI commercial operations.
• Experience commercializing drugs at Sponsor companies
• Ability to effectively present information to various people as the job requires.
• Ability to identify and resolve problems in a timely manner.
• Ability to work independently and/or as part of a team.
• Ability to display excellent time management skills.
• Ability to display a willingness to make decisions.
• Ability to display original thinking and creativity.
• Ability to hold oneself in a professional manner.
• Ability to adapt to changing work environments.
• Ability to exhibit sound and accurate judgment.
• Ability to demonstrate attention to detail.

The hiring rate for this position is $122,000-$137,250 plus eligibility for an 15% annual performance bonus. Final offer amounts are determined by multiple factors, including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), a flexible spending account, and a 401(k) plan.

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Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.