Director of Radiopharmaceutical Manufacturing

Who we are

Abdera Therapeutics Inc. is a precision oncology company developing next-generation targeted radiation therapies- one of the most cutting-edge and highly promising areas of drug development. The company is built on a proprietary modular technology platform optimized for the delivery of radioisotopes to selectively destroy tumor cells while sparing healthy cells. Abdera is using this platform to enable the rapid development of a broad range of safe and efficacious therapies serving cancer patients with limited treatment options.

Abdera Therapeutics is growing rapidly and seeking key new team members who thrive at the cutting-edge of innovation. Come join us and be a part of the ground-breaking team set to unlock the power of targeted radiotherapy!

What we look for

At Abdera Therapeutics, we are looking for curious and committed individuals who are ready for the opportunity to transform the way people living with cancer can be treated. We are relentless in our focus to offer new hope to families facing devastating diagnoses. We are in search of team members who work collaboratively with a diverse group of colleagues, respectfully engaging one another while collectively and inclusively tackling any challenges we may face. We are building an exciting and fast paced company passionate about discovering and developing tomorrow’s most innovative cancer therapies.

Abdera is seeking a Director of Radiopharmaceutical Manufacturing to lead the activities related to the clinical manufacturing of the company investigational products. The candidate will develop and maintain the manufacturing operations in alignment with the company portfolio needs, the clinical demand, and the tech ops team roadmap. In this function, the candidate will be leading the transfer of methods and data to develop cGMP compliant processes and clinical drug product specifications, develop the CDMO network and oversight the manufacturing operations. This role will require frequent travel to the manufacturing locations (up to 40%).

This is a remote position.  Priority given to those living in New Jersey, Indiana, Boston or Philadelphia 

Salary Range: 195 - 225k
 

Principal Responsibilities

• Develop the Manufacturing Operations
• Working with a multidisciplinary team, to define the manufacturing requirements for
• Abdera’s investigational products (drug product and patient doses).
• For each new program, lead the RFP team to review, assess technical fit and select the appropriate CDMO for development and manufacturing of Abdera’s novel product
• Lead the manufacturing operations development including:
• Create technology transfer package for CDMO’s by working closely with the pre-clinical, R&D, CMC process development team.
• Define and manage DP technology transfer and manufacturing readiness
• timelines.
• Design study / experiments to determine suitable process flow, process
• conditions, materials selection, acceptable range, etc. to enable process lock
• Closely partner with antibody and conjugation process development lead and supply chain to ensure critical materials readiness (such as conjugate isotopes).
• Partner with external/internal development lab to define IND enabling study protocols, review study run data, provide feedback throughout the development process
• Lead the execution (with CDMO) of the process qualification and validation campaign and prepare the relevant reports and data for the relevant IND sections.
• Write relevant CMC sections and supporting reports for submission to regulatory agencies
• Execute clinical readiness activities (such as compatibility and transportation studies, aseptic process qualification) to enable clinical manufacturing.
• Manage the Manufacturing Operations
• Provide real-time oversight (remote or in-person) of the manufacturing activities during technology transfer or routine production at the CDMO sites.
• Report on manufacturing event (e.g.: failure, delay, deviation), and provide impact assessment to the cross-functional and technical operations teams.
• Lead the deployment and validation of process changes, such as improvements, scale up, new material introduction.
• Develop tools for organizing and tracking manufacturing activities with the external partners.
• Maintain KPI and internal reports. Technical Support 
• Partner with internal CMC team, provide technical direction to external CDMO to author manufacturing documentation including specification, analytical method, batch records, protocols, etc.
• Partner with Quality to provide periodic technical review of manufacturing data, including analysis of trends
• Partner with Quality, Supply Chain, and manufacturing, identify opportunities for risk reduction and continuous improvement within the cGMP manufacturing process
• Provide technical impact assessment to support Quality/Regulatory assessments including but not limited to batch release, change control, quality events (deviations, OOs, CAPAs).

Qualifications, Education & Experience

• MSc or PhD in scientific fields with 7+ years of experience in the pharmaceutical
• industry, including radiopharmaceuticals. Priority given to candidates with experience
• with therapeutic radiopharmaceuticals and radiometals.
• Knowledge of cGMP requirements, aseptic process, equipment and process
• qualification.
• Understanding of the nuclear safety regulations, and associated guidelines.
• Proven track record in CDMO selection process and operation management technology transfer, process validation.
• Experience in clinical development and manufacturing in the biotechnology or
• pharmaceutical industry.
• Experience working with antibodies, imaging and therapeutics radiometals.

Skills and Abilities

· Good understanding of cGMP and FDA regulations and guidelines relating to

manufacturing activities.

· Excellent written and verbal communication skills; strong communicator and influencer

within all levels of the organization, including executive leadership

· Strong analytical capabilities, including quantitative and qualitative assessment skills

and demonstrated critical thinking skills

· Ability to critically evaluate and troubleshoot complex problems

· Strong problem-solving skills

· Ability to build rapport with all levels of organization

· Team-oriented, progressive thinker who enjoys participating in an innovative and creative work environment
· Ability to operate in a fast-paced, multi-disciplinary industrial environment.

Abdera is an equal opportunity employer that is committed to diversity and inclusion in the workplace. At Abdera, we prohibit harassment of any kind and any form of discrimination including but not limited to discrimination based on race, color, sex, religion, marital status, sexual orientation, national origin, disability, veteran status, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.

This commitment is applicable to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship.