Lannett Company, Inc.
Director Product Development
Lannett Company, Inc., Feasterville Trevose, Pennsylvania, United States, 19053
Join to apply for the
Director Product Development
role at
Lannett Company, Inc. Join to apply for the
Director Product Development
role at
Lannett Company, Inc. Job Summary
Apply promptly! A high volume of applicants is expected for the role as detailed below, do not wait to send your CV.
The Director of Product Development is a supervisory role responsible for the oversight, timely execution and management of all internal and external development projects starting from project initiation through FDA approval and transfer to the commercial manufacturing site, if applicable. Additionally, this position is responsible for the oversight and training of employees at all junior levels within the Product Development organization. Job Summary
The Director of Product Development is a supervisory role responsible for the oversight, timely execution and management of all internal and external development projects starting from project initiation through FDA approval and transfer to the commercial manufacturing site, if applicable. Additionally, this position is responsible for the oversight and training of employees at all junior levels within the Product Development organization.
Responsibilities
Oversee portfolio projects through all phases of development including diligence, planning, API selection, legal assessments, literature reviews, execution, FDA filing, approval, and successful transfer to commercial sites Oversee the timely development of drug product formulations and manufacturing processes which meet FDA stability and bioequivalence requirements and are capable of being produced at commercial scale Oversee the external team to advance formulation development, process development, process characterization, technology transfer, and regulatory authoring of development projects within the defined timelines Oversee the design and execution of detailed experiments using risk assessments, appropriate target product profiles, QbD principles, and process characterization/modeling techniques to develop and understand development processes, whether internally or externally developed Support authoring and review of regulatory submission documents and deficiency responses Manage resources to ensure timely completion of projects within budget, including oversight of external partners Collaborate with other R&D scientific leaders to ensure project specific requirements are met Provide guidance and advice in cross-functional meetings Work with external partners and provide guidance and assistance as needed Oversee the entire clinical plan for each project, including studies needed, trial design, number of participants, etc. Oversee the clinical staff to ensure timely conduct of clinical trials and compliance to study protocol, applicable guidances and SOPs Review statements of work (SOW), payment terms and milestones Reviews clinical study protocols, reports and summary tables for ANDA/ IND/NDA/ filings Coordinate alignment on the final clinical study protocol for execution Oversee the execution of study timelines Oversee the receipt of final study reports in FDA compliant format and help resolve any issues identified, as needed Oversee the clinical trial permission application process to foreign regulatory agencies and assist in export of investigational products to clinical CROs in foreign countries Oversee multidisciplinary activities for successful clinical trial applications and conduct of clinical studies Assist in monitoring clinical studies onsite or remotely and/or appoint external monitors to monitor study conduct on-site Review and approval monitoring reports Oversee the CRO selection process Lead, develop and mentor scientists in support of the company’s goals for the pipeline portfolio Lead the PD function to develop and implement strategies for driving programs towards key milestones and objectives Prepare, review and approve performance reviews, performance improvement plans, disciplinary actions, job descriptions, training plans, and employee development plans Set and assess department and individual review goals Oversee training and personal development programs for department employees Influence, motivate, and energize employees at all levels Maintain expertise in product development and regulatory requirements Interact with key stakeholders (Operations, Quality, Commercial, Analytical, Clinical, Regulatory, External Partners, etc.) to define and optimize business processes maximizing agility and consistency Participate with the leadership team in charting the future direction and growth of the organization, hiring, resourcing, budget, etc. Other duties as assigned
Experience
Master's degree required 8 plus years in pharmaceutical product development in a supervisory/management role
Other Skills
Strong leadership and management skills, including mentorship of colleagues Strong analytical and problem-solving skills Strong organizational skills A high level of integrity Ability to work independently and in a team environment Ability to successfully negotiate and drive change around processes Ability to drive process improvement initiatives – must be able to understand and evaluate current processes and make recommendations for improvements A history of demonstrating successful negotiation and relationship management skills Ability to work well with a variety of personality types, to motivate those you interact with and take control of processes/situations as needed while maintaining a customer-service focused attitude A strategic thinker, planner, and implementer Effective verbal and written communication Strong scientific and regulatory understanding of product development for ANDA/NDA FDA submissions including scientific writing skills and documentation review skills Ability to collaborate effectively cross-functionally and with external partners Proficient with pharmaceutical industry business processes: change control, deviations, SOPs, protocols, reports, etc. Working knowledge of statistics and data analysis Proficient in Microsoft Office and applicable statistical software Seniority level
Seniority levelDirector Employment type
Employment typeFull-time Job function
Job functionProduct Management and Marketing IndustriesPharmaceutical Manufacturing Referrals increase your chances of interviewing at Lannett Company, Inc. by 2x Sign in to set job alerts for “Director of Product Development” roles.Vice President of Digital Product & Development Willow Grove, PA $175,000.00-$200,000.00 1 week ago Philadelphia, PA $200,000.00-$260,000.00 1 week ago Greater Philadelphia $275,000.00-$315,000.00 5 days ago Merchantville, NJ $160,000.00-$180,000.00 5 days ago Senior Director of Product Management – Virtual Agent Greater Philadelphia $215,000.00-$275,000.00 5 days ago New Jersey, United States $164,000.00-$215,250.00 1 week ago Director of Product Management, MarketplaceDirector of Technical Product Management, Gen-AIDirector, Product Management - Fleet Operations PortfolioVP, Product Line Management, General Liability Greater Philadelphia $150,200.00-$202,770.00 2 weeks ago Director, Product Managment, IQVIA Digital Wayne, PA $114,400.00-$319,000.00 4 days ago Director of Investment and Product Solutions (East coast based) New Jersey, United States $198,810.00-$242,990.00 1 week ago Cherry Hill, NJ $120,000.00-$175,000.00 1 week ago New Jersey, United States $114,000.00-$170,000.00 8 hours ago Greater Philadelphia $100,000.00-$115,000.00 6 days ago Director, Product & Pipeline CommunicationsDirector of Product Management, Trust & SafetySenior Solutions Director, Primary Eye Care New Jersey, United States $220,000.00-$280,000.00 4 days ago Product Development Director, Automation Systems Philadelphia, PA $85,000.00-$105,000.00 2 months ago Product Director, Health IT Strategy & Activation – Neuroscience Franchise Titusville, NJ $120,000.00-$207,000.00 6 days ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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Director Product Development
role at
Lannett Company, Inc. Join to apply for the
Director Product Development
role at
Lannett Company, Inc. Job Summary
Apply promptly! A high volume of applicants is expected for the role as detailed below, do not wait to send your CV.
The Director of Product Development is a supervisory role responsible for the oversight, timely execution and management of all internal and external development projects starting from project initiation through FDA approval and transfer to the commercial manufacturing site, if applicable. Additionally, this position is responsible for the oversight and training of employees at all junior levels within the Product Development organization. Job Summary
The Director of Product Development is a supervisory role responsible for the oversight, timely execution and management of all internal and external development projects starting from project initiation through FDA approval and transfer to the commercial manufacturing site, if applicable. Additionally, this position is responsible for the oversight and training of employees at all junior levels within the Product Development organization.
Responsibilities
Oversee portfolio projects through all phases of development including diligence, planning, API selection, legal assessments, literature reviews, execution, FDA filing, approval, and successful transfer to commercial sites Oversee the timely development of drug product formulations and manufacturing processes which meet FDA stability and bioequivalence requirements and are capable of being produced at commercial scale Oversee the external team to advance formulation development, process development, process characterization, technology transfer, and regulatory authoring of development projects within the defined timelines Oversee the design and execution of detailed experiments using risk assessments, appropriate target product profiles, QbD principles, and process characterization/modeling techniques to develop and understand development processes, whether internally or externally developed Support authoring and review of regulatory submission documents and deficiency responses Manage resources to ensure timely completion of projects within budget, including oversight of external partners Collaborate with other R&D scientific leaders to ensure project specific requirements are met Provide guidance and advice in cross-functional meetings Work with external partners and provide guidance and assistance as needed Oversee the entire clinical plan for each project, including studies needed, trial design, number of participants, etc. Oversee the clinical staff to ensure timely conduct of clinical trials and compliance to study protocol, applicable guidances and SOPs Review statements of work (SOW), payment terms and milestones Reviews clinical study protocols, reports and summary tables for ANDA/ IND/NDA/ filings Coordinate alignment on the final clinical study protocol for execution Oversee the execution of study timelines Oversee the receipt of final study reports in FDA compliant format and help resolve any issues identified, as needed Oversee the clinical trial permission application process to foreign regulatory agencies and assist in export of investigational products to clinical CROs in foreign countries Oversee multidisciplinary activities for successful clinical trial applications and conduct of clinical studies Assist in monitoring clinical studies onsite or remotely and/or appoint external monitors to monitor study conduct on-site Review and approval monitoring reports Oversee the CRO selection process Lead, develop and mentor scientists in support of the company’s goals for the pipeline portfolio Lead the PD function to develop and implement strategies for driving programs towards key milestones and objectives Prepare, review and approve performance reviews, performance improvement plans, disciplinary actions, job descriptions, training plans, and employee development plans Set and assess department and individual review goals Oversee training and personal development programs for department employees Influence, motivate, and energize employees at all levels Maintain expertise in product development and regulatory requirements Interact with key stakeholders (Operations, Quality, Commercial, Analytical, Clinical, Regulatory, External Partners, etc.) to define and optimize business processes maximizing agility and consistency Participate with the leadership team in charting the future direction and growth of the organization, hiring, resourcing, budget, etc. Other duties as assigned
Experience
Master's degree required 8 plus years in pharmaceutical product development in a supervisory/management role
Other Skills
Strong leadership and management skills, including mentorship of colleagues Strong analytical and problem-solving skills Strong organizational skills A high level of integrity Ability to work independently and in a team environment Ability to successfully negotiate and drive change around processes Ability to drive process improvement initiatives – must be able to understand and evaluate current processes and make recommendations for improvements A history of demonstrating successful negotiation and relationship management skills Ability to work well with a variety of personality types, to motivate those you interact with and take control of processes/situations as needed while maintaining a customer-service focused attitude A strategic thinker, planner, and implementer Effective verbal and written communication Strong scientific and regulatory understanding of product development for ANDA/NDA FDA submissions including scientific writing skills and documentation review skills Ability to collaborate effectively cross-functionally and with external partners Proficient with pharmaceutical industry business processes: change control, deviations, SOPs, protocols, reports, etc. Working knowledge of statistics and data analysis Proficient in Microsoft Office and applicable statistical software Seniority level
Seniority levelDirector Employment type
Employment typeFull-time Job function
Job functionProduct Management and Marketing IndustriesPharmaceutical Manufacturing Referrals increase your chances of interviewing at Lannett Company, Inc. by 2x Sign in to set job alerts for “Director of Product Development” roles.Vice President of Digital Product & Development Willow Grove, PA $175,000.00-$200,000.00 1 week ago Philadelphia, PA $200,000.00-$260,000.00 1 week ago Greater Philadelphia $275,000.00-$315,000.00 5 days ago Merchantville, NJ $160,000.00-$180,000.00 5 days ago Senior Director of Product Management – Virtual Agent Greater Philadelphia $215,000.00-$275,000.00 5 days ago New Jersey, United States $164,000.00-$215,250.00 1 week ago Director of Product Management, MarketplaceDirector of Technical Product Management, Gen-AIDirector, Product Management - Fleet Operations PortfolioVP, Product Line Management, General Liability Greater Philadelphia $150,200.00-$202,770.00 2 weeks ago Director, Product Managment, IQVIA Digital Wayne, PA $114,400.00-$319,000.00 4 days ago Director of Investment and Product Solutions (East coast based) New Jersey, United States $198,810.00-$242,990.00 1 week ago Cherry Hill, NJ $120,000.00-$175,000.00 1 week ago New Jersey, United States $114,000.00-$170,000.00 8 hours ago Greater Philadelphia $100,000.00-$115,000.00 6 days ago Director, Product & Pipeline CommunicationsDirector of Product Management, Trust & SafetySenior Solutions Director, Primary Eye Care New Jersey, United States $220,000.00-$280,000.00 4 days ago Product Development Director, Automation Systems Philadelphia, PA $85,000.00-$105,000.00 2 months ago Product Director, Health IT Strategy & Activation – Neuroscience Franchise Titusville, NJ $120,000.00-$207,000.00 6 days ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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