Manager, Product Development

Accountabilities

• Planning and evaluating the transfer of manufacturing and testing procedures established by internal product development teams and external product sponsors for our network of cGMP manufacturing facilities.
• Plan and deploy the necessary resources to generate all study protocols and controlled documentation necessary to enable the technology transfer and qualification of contracted products.
• Administrate, track and report (execute where necessary) on the manufacturing and testing activities required for process qualification and method validation according to study protocols and standard operating procedures. Generate study reports where required.
• Collaborate and support execution of equipment qualification, computer system validation, and cleaning verification protocols developed in partnership with validations personnel.
• Lead and/or support investigations and document deviations and exceptions occurring during technology transfer.
• Train facility personnel on new manufacturing and testing procedures and provide routine production support following completion of technology transfers.
• Enable a culture of free communication on all issues related to safety, quality, and compliance to leadership.

Responsibilities

• Ensure a high degree of compliance with relevant cGMP and regulatory requirements across all managed technology transfer, manufacturing, and testing activities.
• Partner with business development during the evaluation of new CDMO opportunities for local pre-commercial manufacturing and testing facilities.
• Support the development of and provide functional leadership for technology transfer programs in related facilities.
• Develop, monitor, and report performance indicators to highlight progress, risks, and mitigation strategies for relevant technology transfer projects.
• Provide technical support as a legacy owner of sponsor products manufactured at relevant facilities.

Qualifications

• Bachelor’s degree in engineering or a physical science with at least five years of experience working in a GMP environment in the pharmaceutical or biotechnology industry. A background in product research and development preferred.
• Demonstrated experience in the operation, use, and maintenance of pharmaceutical production and analytical equipment. Direct experience in the manufacture and testing of radiopharmaceutical products preferred.
• Foundational expertise in the setup, operation, and maintenance of conventional analytical instrumentation (HPLC/GC/TLC/etc.) and modern chromatography data systems.
• Ability to work in a controlled environment requiring special attention to environmental, health, and safety regulations. Position may require lifting or moving equipment weighing up to 40 lbs.
• Commitment to maintain data integrity through strict adherence to standardized procedures and relevant compliance requirements, including the ability to clearly document all work activities in a timely manner.
• Excellent interpersonal skills, including the ability to influence others, resolve challenges diplomatically, and build strong working relationships across departments. Exceptional oral and written communication skills for effective interaction with all levels of employees, senior leadership, and external partners.
• Desire to create, develop, and mature manufacturing and testing processes, and facility and systems infrastructure, to streamline operational efficiency across a broad range of products.
• Flexibility to work periodic off-shift hours to accommodate routine production and testing schedules among qualified facilities.
• Prior experience leading technology transfer, and/or manufacturing and testing operations within a biotechnology, pharmaceutical, or radiopharmaceutical company across all phases of product development.
• Experience working with contract manufacturing as well as working with collaboration partners.

Professional Qualifications

• Deep technical and scientific competencies across multiple modalities.
• Exceptional interpersonal skills including the ability to influence behaviors and resolve challenges with poise, tact and diplomacy.
• Demonstrated knowledge and understanding of relevant compliance principals and requirements as applied to diagnostic and therapeutic radiopharmaceutical products.
• Demonstrated ability to analyze and extrapolate data, and hypothesize, plan and implement scientific strategies.

Personal Characteristics

• A proven ability to operate effectively in a rapidly changing environment where analytical skills and agility are equally as important.
• A self-aware, self-motivated, self-confident individual who is comfortable operating with minimal direction and who thrives in a dynamic environment.
• An individual of unquestioned personal integrity who will be viewed as trustworthy both within the company, as well as with external relations.
• A mission-driven individual with high energy and high levels of perseverance.

Anticipated salary range

$105,100.00-$150,100.00

Benefits

• Medical, dental and vision coverage
• Paid time off plan
• Health savings account (HSA)
• 401k savings plan
• Access to wages before pay day with myFlexPay
• Flexible spending accounts (FSAs)
• Short- and long-term disability coverage
• Work-Life resources
• Paid parental leave
• Healthy lifestyle programs