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About Morphic Therapeutic

Morphic Therapeutic is a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, including autoimmune, cardiovascular and metabolic diseases, fibrosis and cancer. In collaboration with AbbVie, Janssen and Schrödinger, Morphic is advancing its pipeline and discovery activities using its proprietary MInT technology platform which leverages the Company’s unique understanding of integrin structure and biology. For more information, visit www.morphictx.com.

Morphic is advancing both partnered and fully-owned oral integrin therapeutic candidates with the initial clinical trials beginning in the 2020. Our immediate focus is on the areas where the clinical activity of antibody inhibitors of integrins is precedented, thus enabling a rapid path to clinical proof-of-concept. Morphic Therapeutic is located in the AstraZeneca BioHub in Waltham, MA. We are seeking a highly talented and motivated individual to join our culture of teamwork, craftsmanship, tenacity, compassion, and integrity.

Job Description:  Morphic Therapeutic is seeking a highly motivated, experienced, and accomplished cheminformatics/data scientist. This person will work closely with Morphic and partnered scientists to deliver modern cheminformatic capabilities to project teams, aiding in the advancement of multiple early – late stage projects. At the same time, the successful candidate will contribute to the design and execution of the overall data strategy for the company.

Responsibilities

• Design, implement and maintain robust tools, methods, visualizations, etc. to enhance the digestion of multi-parameter structure activity relationships

• Work closely with internal medicinal chemists, biologists, DMPK and other scientists to address current informatics needs and implement workable solutions

• Collaborate with internal IT department on building company wide data solutions

• Build strong relationships with internal and external scientists and work in a highly collaborative manner

• Advance projects through use of these tools directly towards clinical candidates to impact patients

Qualifications

• Ph.D. in relevant scientific field and 5+ years of industry experience

• Cheminformatics expertise, such as, matched molecular pair analyses, chemical reaction/library enumeration, 2D/3D similarity, clustering, dimensionality reduction techniques that are related to data mining and data visualizations

• Experience with enterprise informatics systems such as Knime, Pipeline Pilot, SQL databases and data warehouses

• Strong scientific programming skills (Python, etc.) and pipelining tools

• Familiarity with cloud computing environments (Google, AWS)

• Demonstrated ability to think logically and critically to address cheminformatics needs across multiple projects

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.

Click Here to Apply Now!

About Morphic Therapeutic

Morphic Therapeutic is a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, including autoimmune, cardiovascular and metabolic diseases, fibrosis and cancer. In collaboration with AbbVie, Janssen and Schrödinger, Morphic is advancing its pipeline and discovery activities using its proprietary MInT technology platform which leverages the Company’s unique understanding of integrin structure and biology. For more information, visit www.morphictx.com.

Morphic is advancing both partnered and fully-owned oral integrin therapeutic candidates with the initial clinical trials beginning in the 2020. Our immediate focus is on the areas where the clinical activity of antibody inhibitors of integrins is precedented, thus enabling a rapid path to clinical proof-of-concept. Morphic Therapeutic is located in the AstraZeneca BioHub in Waltham, MA. We are seeking a highly talented and motivated individual to join our culture of teamwork, craftsmanship, tenacity, compassion, and integrity.

Job Description:

The Director, Pharmacovigilance will report to the Chief Medical Officer and will be a key member of Morphic clinical team.  The individual will lead and manage the Pharmacovigilance function for all product candidates globally, act as a key contributor to clinical development plans, and manage all relevant reporting to global health regulatory authorities.

Essential Job Functions:

  • Manages and oversees the company’s drug safety and pharmacovigilance process.
  • Manages compliance with standard operating procedures, regulatory safety, and pharmacovigilance in compliance with national and international regulations, such as the Food and Drug Administration (FDA) and World Health Organization, global, regional and country regulations for the reporting of adverse events to regulatory agencies.
  • Coordinates the development of guidelines and ensures the uniform and timely processing of adverse event reports.
  • Interfaces with internal and external collaborators to develop programs and processes to meet regulatory reporting requirements
  • With CMO, facilitates PI interactions as needed to review adverse events, including potential SUSARs, on an as-needed basis
  • Drafts, finalizes, and implements safety data sharing and safety management plans on all Morphic-sponsored studies with and for all clinical CROs working with Morphic.
  • Oversees the development and preparation of reports for company management as well as external regulatory agencies.
  • Manages and conducts ongoing safety surveillance on company products.
  • Oversees the preparation of new drug application safety updates, investigational new drug safety reports, investigator communications, product labeling/package inserts and other reports, as necessary.
  • Participates in oversight of ongoing clinical trials and in the preparation of study concepts, synopses, protocols and key regulatory documents (e.g. IB updates, DSURs, new drug applications[NDAs]) with respect to drug safety.

Qualification:

Required

  • PharmD, RN or other relevant clinical discipline.
  • 8+ years of related experience in pharmaceutical or biotech industry, or equivalent.
  • Strong ability to work collaboratively in dynamic small teams of internal and external partners that are a part of a fast-paced environment
  • Excellent critical data analysis skills (clinical/systems/processes/compliance).
  • Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
  • In-depth knowledge of US and international pharmacovigilance regulations, FDA requirements, international guidelines (ICH/CIOMS) with experience in their practical application.
  • In-depth understanding of pharmacovigilance processes, regulatory compliance, and standardization.
  • Pharmacovigilance data systems experience is required.

Desired

  • 3+ years of progressive clinical development experience, preferably in pharmacovigilance, at a pharmaceutical or biotechnology company
  • Broad experience in clinical trial design (phases 1 to 3) and clinical data interpretation
  • Working knowledge of FDA and EMA regulatory landscapes, GCP, and ICH guidelines

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.

Click Here to Apply Now!

About Morphic Therapeutic

Morphic Therapeutic is a biopharmaceutical company developing a new   generation of oral integrin therapies for the treatment of serious   chronic diseases, including autoimmune, cardiovascular and metabolic   diseases, fibrosis and cancer. In collaboration with AbbVie, Janssen  and  Schrödinger, Morphic is advancing its pipeline and discovery  activities  using its proprietary MInT technology platform which  leverages the  Company’s unique understanding of integrin structure and  biology. For  more information, visit www.morphictx.com.

Morphic is advancing both partnered and fully-owned oral integrin   therapeutic candidates with the initial clinical trials beginning in  the  2020. Our immediate focus is on the areas where the clinical  activity  of antibody inhibitors of integrins is precedented, thus  enabling a  rapid path to clinical proof-of-concept. Morphic Therapeutic  is located  in the AstraZeneca BioHub in Waltham, MA. We are seeking a  highly  talented and motivated individual to join our culture of  teamwork,  craftsmanship, tenacity, compassion, and integrity.

Job Description:

Associate Director, Translational Sciences will establish and lead the Cell and Tissue Imaging function at Morphic Therapeutic to support biomarker and target discovery/validation. The successful candidate will be a skilled team player who is able to work in a highly collaborative function, working at the interface between research and development. Candidates should have experience in sample preparation and imaging techniques and a degree in underlying biologic pathways.

Essential Job Functions:

· Display Morphic core values of craftsmanship, tenacity, teamwork, integrity, and compassion.

· Experience in preparing samples for analyses including tissue sectioning, fixation and staining to allow for effective contracting of these activities to 3rd-party vendors.

· Skilled in antibody selection and validation for various imaging methods.

· Perform imaging techniques (e.g., immunohistochemistry, immunocytochemistry, immunofluorescence, in situ hybridization, multiplexing).

· Maintain instrumentation and monitor for relevant new technology.

· Use software for scanning, image acquisition and quantification.

· Help to maintain organized sample library/repository of relevant samples for various diseases.

· Collaborate with academic labs.

· Outsource and manage biomarker imaging methods and method validations by transferring to contract labs.

· Preparation of presentations, reports and publications of results.

Qualifications:

Required

· PhD with 5+ or MSc with 10+ years of imaging experience in academia or biotech/pharma with a degree in biology or related fields.

· Flexible, collaborative and able to thrive in a fast-paced biotech environment.

· Able to work independently in troubleshooting experiments and show curiosity and sophistication in experimental design.

· Experience in histology including tissue sample preparation.

· Extensive hands-on IHC experience, including chromogenic and fluorescent staining, along with  multiplex immunofluorescence assay development and validation.

· Experience with imaging analysis (e.g., Visiopharm, Halo) and data analysis software (e.g., Excel, Prism).

· Strong interest in biomarker discovery, characterization, method validation and application in clinical studies is essential.

· Prior experience in immuno-oncology, fibrosis or immunology.

Desired

· Experience in immuno-oncology and application of IHC/tissue imaging biomarkers in clinical development preferred.

· Experience with in situ hybridization or multiplex immunofluorescence staining and associated analysis (e.g., Vectra Polaris) not required but a plus.

· Experience in other imaging methods (eg. RNAscope) or multiplex analysis of protein expression in tissues (eg. multiplex ion beam imaging, mass cytometry, spatial proteomics) would be 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 and a  generous  vacation and holiday schedule.

Click Here to Apply Now!

About Morphic Therapeutic

Morphic Therapeutic is a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, including autoimmune, cardiovascular and metabolic diseases, fibrosis and cancer. In collaboration with AbbVie, Janssen and Schrödinger, Morphic is advancing its pipeline and discovery activities using its proprietary MInT technology platform which leverages the Company’s unique understanding of integrin structure and biology. For more information, visit www.morphictx.com.

Morphic is advancing both partnered and fully-owned oral integrin therapeutic candidates with the initial clinical trials beginning in the 2020. Our immediate focus is on the areas where the clinical activity of antibody inhibitors of integrins is precedented, thus enabling a rapid path to clinical proof-of-concept. Morphic Therapeutic is located in the AstraZeneca BioHub in Waltham, MA. We are seeking a highly talented and motivated individual to join our culture of teamwork, craftsmanship, tenacity, compassion, and integrity.

Job description

The successful candidate will be responsible for planning, coordinating, managing formulation development, clinical manufacturing/packaging activities at CDMOs and contribute to writing relevant regulatory sections for submissions. This individual will also provide scientific input and suggestions to Research and Toxicology groups for pre-clinical formulations. In addition, this individual will lead and/or contribute to various departmental and cross-functional team as assigned. This position will report to the Director of Drug Product Development and Manufacturing.

Responsibilities

  • Provide oversight and coordination for outsourced pre-formulation, formulation, and clinical manufacturing/packaging activities.
  • Work closely with CDMO team to support day to day activities for formulation development and clinical manufacturing including data trending and monitoring.
  • Work closely with Discovery and Toxicology teams to provide formulation support.
  • Develop formulation development plan consistent with project team timeline and strategy to ensure deliverables.
  • Prepare/review and approve technical protocols/reports and clinical manufacturing/packaging batch records.
  • Author and review relevant sections of INDs, IMPDs.
  • Conducts data input, analysis, tracking and organizing project information.
  • Build collaborative and long-term relationships with CDMO partners.
  • Up to 10% travel required.

Qualifications

  • Goal-oriented and self-motivated individual with the ability to think and work independently.
  • Minimum of 7 years relevant experience in formulation development with strong emphasis on oral solid dosage forms (both IR and ER).
  • PhD in Pharmaceutics, chemical engineering with 7 years of experience or an equivalent combination of education (MS) and drug product development experience with minimum 10 years of experience.
  • Excellent communication and interpersonal skills.
  • Excellent technical writing skills.
  • Good understanding of ICH, FDA and EMA guidelines pertaining to drug product development.
  • Experience of a wide range of dosage forms and delivery systems (e.g., oral liquids) and various drug delivery technologies (a plus).
  • Experience in early to late stages of drug product development.
  • Strong project management skills and a team player.

 

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.

Click Here to Apply Now!

About Morphic Therapeutic

Morphic Therapeutic is a biopharmaceutical company developing a new  generation of oral integrin therapies for the treatment of serious  chronic diseases, including autoimmune, cardiovascular and metabolic  diseases, fibrosis and cancer. In collaboration with AbbVie, Janssen and  Schrödinger, Morphic is advancing its pipeline and discovery activities  using its proprietary MInT technology platform which leverages the  Company’s unique understanding of integrin structure and biology. For  more information, visit www.morphictx.com.

Morphic is advancing both partnered and fully-owned oral integrin  therapeutic candidates with the initial clinical trials beginning in the  2020. Our immediate focus is on the areas where the clinical activity  of antibody inhibitors of integrins is precedented, thus enabling a  rapid path to clinical proof-of-concept. Morphic Therapeutic is located  in the AstraZeneca BioHub in Waltham, MA. We are seeking a highly  talented and motivated individual to join our culture of teamwork,  craftsmanship, tenacity, compassion, and integrity.

Job Description:

The Associate Director of Program Management is a highly visible role and critical to the successful development of Morphic Therapeutic compounds. This person will work closely with the program team(s) to ensure the timely execution of development activities. The successful candidate will be a highly organized, enthusiastic team player who will be proactive in building relationships with internal

and external subject matter experts. She or he will report to the Executive Director, Portfolio, Program, and Alliance Management.

Essential Job Functions:

• Manage one or more internal programs (both preclinical and/or clinical assets) including drafting

and updating the integrated development plan and timeline, quarterly risk mapping exercises, and monthly dashboards.

• Work with the Program Leader(s) and functional experts to develop and execute program plans.

• Ensure effective communication within the team and more broadly by preparing meeting agendas, presentation materials, meeting minutes, and following-up on action items.

• Liaise with Finance for program budgeting and reforecasting exercises as well as variance analysis.

• Provide program and functional area updates with team members and senior leadership.

• Build strong, collaborative relationships with key stakeholders within the company.

• Develop and maintain timelines for programs and functional teams, ensuring that milestones are met both internally and with external partners.

• Align corporate goals with program team goals and monitor functional activities to confirm progress is on track.

Qualifications:
Required
• 8+ years of experience in pharmaceutical or biotech drug development with 3+ years of
demonstrated program management experience or experience managing cross-functional teams.
Knowledge of the overall drug discovery and development process.
• Strong project management skills – timeline development, risk assessment and mitigation planning,
activity tracking and reporting.
• Adept in the use of project management tools – MS Project, Excel, PowerPoint, and/or other
modeling and visualization tools.
• Ability to thrive in a fast-paced team environment, integrate and influence cross-functional issues,
balance competing priorities effectively, and successfully negotiate desired outcomes.
• Strong collaborative, communication and interpersonal skills. Creative problem-solver.
• Superior attention to detail, coordination, organizational, and time management skills.
• Experience developing program budgets, reforecasting expenses, and analyzing and reporting
variances.

Desired
• Advanced degree in a scientific discipline or MBA is preferred.
• Alliance management experience
• Oncology experience

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.

Click Here to Apply Now!

About Morphic Therapeutic

Morphic Therapeutic is a biopharmaceutical company developing a new  generation of oral integrin therapies for the treatment of serious  chronic diseases, including autoimmune, cardiovascular and metabolic  diseases, fibrosis and cancer. In collaboration with AbbVie, Janssen and  Schrödinger, Morphic is advancing its pipeline and discovery activities  using its proprietary MInT technology platform which leverages the  Company’s unique understanding of integrin structure and biology. For  more information, visit www.morphictx.com.

Morphic is advancing both partnered and fully-owned oral integrin  therapeutic candidates with the initial clinical trials beginning in the  2020. Our immediate focus is on the areas where the clinical activity  of antibody inhibitors of integrins is precedented, thus enabling a  rapid path to clinical proof-of-concept. Morphic Therapeutic is located  in the AstraZeneca BioHub in Waltham, MA. We are seeking a highly  talented and motivated individual to join our culture of teamwork,  craftsmanship, tenacity, compassion, and integrity.

Job Description:

We are looking for a highly energetic and organized individual to orchestra operations of the labs at Morphic Therapeutic. The successful candidate will assure a safe, compliant, and efficient laboratory. Must be self-motivated and able to effectively communicate with multiple lab members. Comfort working in a lab setting is essential.

Essential Job Functions:

Responsibilities include but are not limited to:

• Oversee the development, planning, and implementation of environmental, health and safety policies; develop procedures (chemical safety, shipping, IACUC, ergonomics, illness, and injury prevention, and building safety) used throughout the company.

• Ensure compliance with federal, state, and local regulations pertaining to environmental safety and handle all contact with appropriate agencies.

• Oversee licensed hazardous and radioactive waste disposal and monitors waste handling.

• Develop and oversees company training programs for employees in areas such as compliance training, lab/plant inspection, hazardous material handling, emergency response, industrial hygiene, and life safety.

• Be the point of contact for emergency personnel and manage workers compensation program administration.

• Ensure appropriate corrective action is taken where health and safety hazards exist.

• Select, develop, and evaluate personnel to ensure the efficient operation of the function.

• Collaborate with research leadership, researchers, and assistants.

• Orchestra lab safety and facilities in the company.

Qualification:

Required

• Familiarity with lab environment including laboratory safety protocols.

• 10+ years of laboratory experience in pharma or CRO.

• 8+ years in a supervisory or management role.

• Bachelor’s degree in life sciences field.

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.

Click Here to Apply Now!

About Morphic Therapeutic

Morphic Therapeutic is a biopharmaceutical company developing a new  generation of oral integrin therapies for the treatment of serious  chronic diseases, including autoimmune, cardiovascular and metabolic  diseases, fibrosis and cancer. In collaboration with AbbVie, Janssen and  Schrödinger, Morphic is advancing its pipeline and discovery activities  using its proprietary MInT technology platform which leverages the  Company’s unique understanding of integrin structure and biology. For  more information, visit www.morphictx.com.

Morphic is advancing both partnered and fully-owned oral integrin therapeutic candidates with the initial clinical trials beginning in the 2020. Our immediate focus is on the areas where the clinical activity  of antibody inhibitors of integrins is precedented, thus enabling a  rapid path to clinical proof-of-concept. Morphic Therapeutic is located  in the AstraZeneca BioHub in Waltham, MA. We are seeking a highly  talented and motivated individual to join our culture of teamwork,  craftsmanship, tenacity, compassion, and integrity.

 

Job Description

Morphic is searching for an experienced process chemist to join the Process Development and Manufacturing group within the CMC team. The successful candidate needs to demonstrate a proven track record of developing and manufacturing API for clinical development from early stage up to commercialization. This candidate should also have direct experience working with CROs/CDMOs and authoring drug substance sections for regulatory filings.

Responsibilities

• Responsible for drug substance process design, optimization, scale-up, technology transfer and validation with a focus on non-GMP/GMP manufacturing to meet regulatory and quality expectations for toxicology and clinical supplies while integrating quality risk management principles

• Work with internal project teams, medicinal chemistry, and CROs/CDMOs to manage and deliver high quality API to support research, toxicology, and clinical timelines

• Manage late phase drug development with CDMOs including Process Performance Qualification (PPQ)

• Design and oversee supporting experiments including Fate, Spike and Purge studies, and DOE to enable PPQ

• Represent Process Development and Manufacturing on CMC sub-teams

• Oversee the development of technical solutions to ensure drug substance processes can be successfully demonstrated and delivered

• Independent problem solving and ability to meet project goals

• Ensure relevant data is captured in reports provided by external CROs/CDMOs

• Responsible for writing/reviewing of technical and GMP documents, patent applications, and drug substance sections in regulatory filings

• Contribute to IP/patent related activities for process chemistry

• Build collaborative and long-term relationships with CDMO partners

Minimum Requirements

• Bachelor’s degree in organic chemistry with more than 15 years of applicable experience in a biotech or pharmaceutical environment or Master’s degree in organic chemistry with more than 10 years of applicable experience in a biotech or pharmaceutical environment or pharmaceutical environment or PhD in organic chemistry with more than 5 years of applicable experience in a biotech or pharmaceutical environment

• Experience in managing CROs/CDMOs

• Experience in operating in a cGMP environment

• Excellent organizational, interpersonal and communication skills

• Knowledge and understanding of current ICH guidelines, cGMP guidelines, and related industry practices

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.