If you are interested in a career at Morphic please submit your CV below.
Morphic is seeking a highly-motivated individual with extensive drug development experience to serve as an Associate Director/Director/Senior Director* of CMC. The successful candidate will be responsible for pharmaceutical development planning and execution for all CMC activities including process development, analytical, drug substance and drug product from preclinical development through IND/IMPD filing and subsequently managing drug supply for clinical studies.
- Establish and execute CMC development plan from pre-clinical through clinical development;
- Establish and oversee external operations including, but not limited to process and method development, analytical, formulation, contract manufacturing, testing, packaging and labeling operations for all drug substances and drug products;
- Develop necessary SOPs and guidelines to support external CMC activities;
- Participate in audits of external vendors acting as a CMC expert;
- Review, edit and approve documentation from external vendors;
- Write and review CMC sections of regulatory documentation (e.g. pre- IND, IND/IMPD);
- Work productively and collaboratively with internal personnel and external consultants;
- Serve as a CMC functional area representative on the research project teams;
- Collaborate with finance to prepare and maintain project-related CMC budgets.
- Proactively identify and communicate risks (related to timelines, budgets, resources, compliance, quality, etc.) and develops mitigation plans to facilitate resolution of issues;
- M.S. or Ph.D. in a relevant discipline with a minimum of 10 years of industry experience with direct involvement in the transition of new compounds into the clinic;
- Experience in management of Contract Manufacturing Organizations and leading process development, CMC and GMP manufacturing activities;
- Strong project management skills and ability to develop effective working relationships with consultants, external vendors and internal cross-functional project teams;
- Proven track record in writing and reviewing CMC sections of INDs/IMPDs. Experience in leading or being part of a team through the successful approval of an IND and/or IMPD;
- Solid understanding of cGMP and EMEA and FDA regulations and guidelines;
- Effective working in a “virtual” CMC environment and leading consultants, partners and CDMOs to advance programs.
- Exceptional organizational and time management skills. Ability to handle multiple project and priorities. Desire to work fast-paced, learning-oriented environment.
Morphic Therapeutic is an equal opportunity employer committed to providing an environment that maximizes our employees’ development and achievement goals. We strive to treat each employee as an individual, as we seek to foster a spirit of teamwork to help change patients’ lives. In addition to a competitive compensation we offer a competitive benefits package that includes medical, dental, vision coverage, life insurance, a 401K with company match and a generous vacation and holiday schedule.
* Title level will be determined based on skills and experience.
Morphic Therapeutic is seeking a highly motivated Research Associate in Biochemistry and Structural Biology. The successful candidate will be responsible for expressing and purifying proteins of the Integrin family for use in downstream applications such as assays, structural biology, and biophysical characterization. The position will be part of a multi-disciplinary team at Morphic, working together towards transformative small molecule therapeutics for autoimmune and fibrotic diseases. A strong knowledge of biochemistry is required, lab experience in the areas of tissue culture and protein purification being preferred.
- Design and execute experiments to support research activities and project goals
- Responsible for generating and characterizing high quality protein samples for compound activity profiling and crystallization
- Maintain mammalian tissue cultures and laboratory equipment
- Work within a multifunctional team and collaborate with multiple groups including Biology, Chemistry, and Pharmacology
- BS/MS in biochemistry/biophysics/molecular cell biology or related discipline, with research experience.
- Experience in protein expression and purification
- Experience with AKTA chromatography systems, SDS-PAGE, and western blot.
- Knowledge in basic tissue culture techniques is a plus.
- Knowledge in X-ray crystallography and structural biology is a plus.
- Must demonstrate a good understanding of scientific principles, experimental design, and proper laboratory techniques
- Excellent communication, interpersonal, and organizational skills
Morphic Therapeutic is an equal opportunity employer committed to providing an environment that maximizes our employees’ development and achievement goals. We strive to treat each employee as an individual, as we seek to foster a spirit of teamwork to help change patients’ lives. In addition to a competitive compensation and benefits package that includes medical, dental and vision coverage, a 401K and a generous vacation and holiday schedule.
Description and Responsibilities
Morphic Therapeutic is currently seeking a Research Associate or Senior Research Associate with strong in vitro and in vivo skills for fibrosis research. The candidate will work cross-functionally within the organization to contribute to the areas of immunology, fibrosis, and oncology. The candidate is expected to be multi-tasking and able to execute complex experiments with strong attention to detail under supervision. The candidate should be highly motivated, creative and flexible, possess strong experimental and technical research skills, have excellent communication skills, and collaborate effectively in a team environment. The responsibilities of the candidate include but are not limited to:
- Perform standard procedures in live rodent models
- Perform ex vivo sample analysis
- Establish in vitro cell-based assays independently for anti-fibrotic compound evaluation
- Design and conduct mechanism of action studies for targets of interest
- Analyze experimental results and accurately extract information from the data for presentations to peers and management
B.Sc. degree with a minimum of 3-5 years or M.Sc. degree with a minimum of 1-3 years of industry or academic experience in pharmacology, physiology, pathology or related field.
Required qualifications and skills:
- In vivo skills including routine animal handling, dosing, and relevant in vivo assays
- Proficient with necropsy
- Cellular biology and cell-based assays
- Ex vivo sample processing and analysis
- Demonstrated ability for multi-tasking and high productivity
- Fast learner and show curiosity in new techniques
- Excellent communication, interpersonal, and organizational skills
- Familiarity with rodent models of immunology or fibrosis
- Experience in survival rodent surgery is a plus
Morphic Therapeutic is an equal opportunity employer committed to providing an environment that maximizes our employees’ development and achievement goals. We strive to treat each employee as an individual, as we seek to foster a spirit of teamwork to help change patients’ lives. In addition to a competitive compensation and benefits package that includes medical, dental and vision coverage, a 401K with company match and a generous vacation and holiday schedule.