Acrotech Biopharma Inc
MANAGER, PHARMACEUTICAL OPERATIONS & SUPPLY CHAIN
Acrotech Biopharma Inc, Princeton Junction, New Jersey, United States
MANAGER, PHARMACEUTICAL OPERATIONS & SUPPLY CHAIN
Base pay range: $100,000.00/yr - $120,000.00/yr
About the Company Acrotech is committed to delivering innovative pharmaceutical solutions and maintaining a culture of compliance and excellence.
About the Role The Pharmaceutical Operations & Supply Chain Manager will be responsible for the ongoing commercial, clinical, medical, Ex-USA & Patient Assistance Program supply chain network to include contract manufacturing, Contract Research Organizations, raw material suppliers, clinical & commercial packaging vendors, contract testing labs and cross‑functional oversight of third‑party logistics (3PL) vendors.
Responsibilities
Supply Chain activities: 30‑40%
Pharmaceutical Operations activities: 60‑70%
Product focus: Acrotech promoted portfolio of products & development pipeline
Provide CMC & operational support, including review of Master & Executed batch records and support commercial release of products.
Review technical documents from sending as well as receiving sites and ensure all gaps are identified and mitigated.
Provide technical support, partner with Quality on the documentation systems, as owner of product & vendor related deviations, complaints, changes, CAPA etc, and drive these to closure.
On‑time manufacturing and delivery of trade and sample products to the 3PL distributor and sales reps, avoids product stock‑outs, and always ensure sufficient safety stock inventory.
Support clinical trials with clinical supplies & other requirements, as needed, specific to a trial.
Support medical studies in coordination with the medical team.
Coordinate manufacturing plans and evaluate supply chain redundancy needs, ensuring that necessary product manufacturing and distribution backup resources are in place to avoid failure of supply or distribution to the marketplace in the event of a supply chain disruption.
Responsible for the successful implementation of long‑term supply chain strategy including establishment of necessary company infrastructure, procedures, policies and budgets.
Partner with development, quality, regulatory and other cross‑functional leadership to ensure that the supplier, product distribution and commercial supply agreements are established and ready to support product launches and ongoing supply.
Develop strategic business plans and supply chain continuity.
Promotes supply chain practices with respect to efficiency. Meets or exceeds supply chain performance objectives.
Acts, as needed, to quickly implement corrective and preventive actions (CAPA) in the event of a manufacturing or distribution incident, serious adverse event or recall.
Build a rapport and manage alliances with internal customers and stakeholders such as local business unit heads, business development, legal, finance, quality, technical operations procurement, regulatory, distribution and logistics.
Identification, evaluation (technical & financial) & finalization of contracts with CMO partners.
Finding alternate CMOs and CPOs.
Manage the tech / site transfer project as per agreed timeline and deliver on time launches within agreed budget.
Build & maintain strong business relations with external partners.
Maintain a regular dialogue with CMOs, SCM, quality, clinical, medical & finance to facilitate finished product availability as per the plan.
Timely monthly/weekly reporting, month‑end closure activities.
Ensure and track the progress of projects such as technology transfers, RM/PM vendor implementation, facility upgradations so that there is no business interruption.
Perform regular visits to CMO locations to assess them with respect to but not limited to compliance, performance, project progress, etc.
Qualifications Education and experience requirements are not specified in the provided job description.
Equal Opportunity Statement Acrotech is committed to diversity and inclusivity in the workplace.
Seniority level Mid‑Senior level
Employment type Full‑time
Job function Supply Chain Industry: Biotechnology
#J-18808-Ljbffr
About the Company Acrotech is committed to delivering innovative pharmaceutical solutions and maintaining a culture of compliance and excellence.
About the Role The Pharmaceutical Operations & Supply Chain Manager will be responsible for the ongoing commercial, clinical, medical, Ex-USA & Patient Assistance Program supply chain network to include contract manufacturing, Contract Research Organizations, raw material suppliers, clinical & commercial packaging vendors, contract testing labs and cross‑functional oversight of third‑party logistics (3PL) vendors.
Responsibilities
Supply Chain activities: 30‑40%
Pharmaceutical Operations activities: 60‑70%
Product focus: Acrotech promoted portfolio of products & development pipeline
Provide CMC & operational support, including review of Master & Executed batch records and support commercial release of products.
Review technical documents from sending as well as receiving sites and ensure all gaps are identified and mitigated.
Provide technical support, partner with Quality on the documentation systems, as owner of product & vendor related deviations, complaints, changes, CAPA etc, and drive these to closure.
On‑time manufacturing and delivery of trade and sample products to the 3PL distributor and sales reps, avoids product stock‑outs, and always ensure sufficient safety stock inventory.
Support clinical trials with clinical supplies & other requirements, as needed, specific to a trial.
Support medical studies in coordination with the medical team.
Coordinate manufacturing plans and evaluate supply chain redundancy needs, ensuring that necessary product manufacturing and distribution backup resources are in place to avoid failure of supply or distribution to the marketplace in the event of a supply chain disruption.
Responsible for the successful implementation of long‑term supply chain strategy including establishment of necessary company infrastructure, procedures, policies and budgets.
Partner with development, quality, regulatory and other cross‑functional leadership to ensure that the supplier, product distribution and commercial supply agreements are established and ready to support product launches and ongoing supply.
Develop strategic business plans and supply chain continuity.
Promotes supply chain practices with respect to efficiency. Meets or exceeds supply chain performance objectives.
Acts, as needed, to quickly implement corrective and preventive actions (CAPA) in the event of a manufacturing or distribution incident, serious adverse event or recall.
Build a rapport and manage alliances with internal customers and stakeholders such as local business unit heads, business development, legal, finance, quality, technical operations procurement, regulatory, distribution and logistics.
Identification, evaluation (technical & financial) & finalization of contracts with CMO partners.
Finding alternate CMOs and CPOs.
Manage the tech / site transfer project as per agreed timeline and deliver on time launches within agreed budget.
Build & maintain strong business relations with external partners.
Maintain a regular dialogue with CMOs, SCM, quality, clinical, medical & finance to facilitate finished product availability as per the plan.
Timely monthly/weekly reporting, month‑end closure activities.
Ensure and track the progress of projects such as technology transfers, RM/PM vendor implementation, facility upgradations so that there is no business interruption.
Perform regular visits to CMO locations to assess them with respect to but not limited to compliance, performance, project progress, etc.
Qualifications Education and experience requirements are not specified in the provided job description.
Equal Opportunity Statement Acrotech is committed to diversity and inclusivity in the workplace.
Seniority level Mid‑Senior level
Employment type Full‑time
Job function Supply Chain Industry: Biotechnology
#J-18808-Ljbffr