Director/Global Lead, Clinical Supply Chain Operations
Aimmune Therapeutics
Operations
Bridgewater, NJ, USA
Posted on Friday, April 8, 2022
Position: Director/Global Lead, Clinical Supply Chain Operations
Reports to: VP, Clinical Manufacturing & Supply Chain Operations (Rx/Nx)
Location: Lausanne, Switzerland (Nestle Health Science, Nestle Research Center HQ), New Jersey, USA Option. Hybrid work schedule.
Summary:
The Global Lead, Clinical Supply Chain Operations will work as an integral cross enterprise member in Nestle Health Science, whilst sitting within the Aimmune Clinical Manufacturing & Supply Chain (CM&SC) team. This role will aid in the development of the newly appointed Medical Nutrition (Nx) arm of the CM&SC organization as well as providing ongoing pharmaceutical leadership within the team. The scope of this role includes both investigational pharmaceutical drugs and medical nutrition products as part of Nestle Health Science and Aimmune Pharma pipeline portfolios. The successful candidate will proficiently support various manufacturing & clinical supply operations across Oral Immunotherapy (OIT) & Gastrointestinal (GI) and other newly added pipeline treatments for investigational medicinal products (IMP), Investigational Nutritional Products (INP), Clinical Trial Materials (CTM) and Food Challenge Materials (FCM) used in Aimmune/NHSc clinical and non-clinical studies. The position closely interacts with NHSc & Aimmune’s Clinical Operations, Product Development, Manufacturing, Quality Assurance, and Regulatory groups and with external vendors.
Specific Responsibilities:
- Identify & develop processes (SOPs and WoWs) to bridge Rx/Nx Clinical Supply Operations within compliances of product appropriate regulations.
- Set program level strategy for forecasting, production planning, storage and distribution setup, packaging, labeling, returns, and destruction of IMP/INP/CTM.
- Ensure IMP/INP traceability, accountability and compliance to GCP requirements and applicable GMP requirements.
- Responsible for continuous process improvements on Clinical Trial Supplies time/budget optimization.
- Ensure continuity of clinical and non-clinical supplies with on-time/on-budget delivery performance. Including, but not limited to coordinating demand to manufacturing team, and overseeing storage & distribution activities, troubleshooting escalated issues, continuously providing and monitoring KPIs
- Driving hands on results and results through others via being accountable for global clinical trial supplies availabilities, inventories with demand and manufacturing forecasts.
- Ability to direct, project manage, influence and represent Aimmune CM&SC’s team objectives among cross functional NHSc teams in Nestle HQ, Aimmune, CMOs and global corporate offices, as required.
- IRT/IXRS, Forecasting/Planning eSystems experience is key in working with internal and outside vendors to, design, implement and maintain systems used to automate Clinical Manufacturing and Supply Chain Ops.
- Ability to be PIP in Pack/Label facilities, liaise with QPs as point person for Aimmune external vendors.
- Oversee labeling (in multiple languages, and over labeling), packaging, inventory, distribution, and final reconciliation of IMP/INP/CTM for multi-national clinical studies as assigned.
- Ensure program appropriate import and exports maintain and ensure compliance with all applicable Clinical Trial Material import / export regulations.
- People Manager: Hire, train, retain and inspire existing and future CM&SC staff assigned.
- Lead efficient procurement of study related ancillaries, such as but not limited to food challenge materials.
- Develop and maintain applicable metrics and KPIs to monitor performance relative to clinical trial inventory and planning.
- Provide general and newly assigned Clinical Manufacturing Supply Chain Ops related support, as needed.
Qualifications / Requirements:
- Bachelor’s Degree in applicable discipline, 10 Minimum of years of Medical nutrition or Pharmaceutical industry experience with 5 years within the Clinical Supplies/Manufacturing specialty.
- Experience in managing complex products, Mfg & distribution supply chains of IMP/INP/CTM for global double-blinded, placebo-controlled clinical trials in multiple countries.
- In-depth knowledge of Medical Nutrition guidelines, regulations, operations, and Ways of Working (WoWs)
- High aptitude for learning of the complex GxP & ICH regulated Pharmaceutical Clinical Supply Chains
- Works effectively and independently in a virtual manufacturing & office environment.
- Understanding of Annex 13, 15, 16 as well as ICH guidelines, global label development regulations and guidelines governing conduct of clinical studies a must with experience in cold chain logistics.
- Demonstrated proficient knowledge of international regulations governing transport and distribution of IMP/INP/CTM CTM materials.
- Flexibility to travel on company business as required.
Preferred Experience, Special Skills, Knowledge:
- Robust interpersonal skills and ability to communicate and work effectively in a global multi-functional team environment.
- Excellent written and verbal communication skills.
- Strong project management and computer skills, with proficiency in Microsoft Office Suite; specifically, Excel, Word, PowerPoint and Project.
- Experience with GMP manufacturing for clinical use is a must, food and/or pharmaceutical.
- Accuracy and attention to detail, adaptability, agility, flexibility, independence, and resourcefulness to multi-task as needed to thrive in a dynamic global and virtual company environment is a must.
- Nimble and able to thrive in fast pace ever changing Clinical Mfg & Supply Chain environment.
- Skillful and resourceful with IMP labeling requirements and QP release process. Annex 13, 15 & 16 as well as 21CFR and ability to adjust to Brexit implications.
- MBA, MSc, CSCP/CPM Certification or similar is a plus.
- Broad exposure to multiple dosage forms and extensive SKUs is a plus.
About Aimmune Therapeutics, Inc.
Aimmune Therapeutics, Inc., a Nestlé Health Science Company, is a biopharmaceutical company developing and commercializing treatments for potentially life-threatening food allergies and food digestion & absorption. Aimmune has one FDA-approved medicine for peanut allergy and other investigational therapies in development to treat other food allergies. In the area of food digestion and absorption, we offer treatments for Exocrine Pancreatic Insufficiency (EPI), a disorder where the pancreas does not make enough enzymes due to cystic fibrosis or other conditions. For more information, please visit www.aimmune.com.
Aimmune is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
Aimmune is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.