Sr Scientist-Process Research (DG)

Date Posted: 10/18/2023

Senior Scientist - Process Research
Boston, MA (onsite)

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Senior Scientist in our Process Research group as part of the Synthetic Molecule Process Development (SMPD) department, located at our Cambridge, MA, office.

Pharmaceutical Sciences empowers innovative and flexible teams to enable fast global patient access to high-quality products through a collaborative, data-driven culture that develops and applies adaptive, forward-thinking technologies into predictive and sustainable solutions across a diverse pipeline. As part of Pharmaceutical Sciences, SMPD Process Research is responsible for advancing novel synthetic molecule pharmaceuticals through the pre-clinical stage into early clinical development while operating in a highly dynamic environment with rapidly changing priorities. Key objectives will be the development of robust, safe, and scalable processes for the manufacture of such pharmaceuticals in a fit-for-purpose manner, along with methods for achieving and controlling high standards of purity and quality.

POSITION ACCOUNTABILITIES:
As a subject matter expert in synthetic organic chemistry, the successful candidate combines their expertise in synthetic organic chemistry, reaction mechanisms, and retro-synthetic analysis skills with their demonstrated understanding of the development of phase-appropriate manufacturing processes that are amenable to safe scale-up and efficient enough to rapidly supply program-enabling drug substance in sufficient quantities and quality promptly.

As part of this role, the successful candidate will be driving the technical advancement of a given program by conducting in-house laboratory research toward innovative, value-creating solutions, which guide and augment process development at our external partners. The successful candidate will be accountable for developing and executing complex scientific strategies for one or more pipeline projects, and, within their field of expertise as a Senior Scientist, will actively contribute to decision-making on multidisciplinary technical teams. This includes close interaction with discovery functional lines such as Medicinal Chemistry, DMPK, Drug Safety, and Pharmaceutical Sciences cross-functional and cross-site teams as well as with our external partners (CDMOs).

The successful candidate will be open to embracing the implementation of technologies (e.g. flow chemistry, Process Analytical Technologies (PAT), automation, artificial intelligence, kinetic modeling, etc.) and emerging innovations in organic chemistry (such as photo redox, electrochemistry, etc.) early in the development lifecycle to enhance development capabilities.

DESCRIPTION:
Designs scalable synthetic routes and solves synthetic chemistry problems. Analyzes and interprets scientific data independently. Designs phase-appropriate strategies for reaction optimization, and scale-up demonstration, and conducts troubleshooting experiments to achieve project goals. Develops strategies and independently executes the plan for the preparation of gram-to-kilogram quantities of APIs, intermediates, impurities, and reference standards, and/or assists in the management of such activities at our external CDMOs. Maintains a current understanding of synthetic organic chemistry literature and technology trends/advancements. As necessary, prepares experimental procedures for patent applications and scientific reports as well as tech transfer documents in support of collaborations with external partners (CDMOs). Actively builds the necessary cross-functional and cross-site relationships in support of early-stage Pharmaceutical Sciences development. Serves as a subject matter expert and collaborates with other Pharmaceutical Sciences functions (Analytical Development, Drug Product Development, etc.) in support of the development and implementation of an overall CMC strategy. Ability to lead all or part of the SMPD efforts on a program, represent SMPD in cross-functional meetings and lead technical efforts at multiple CDMOs. Plays an important role in the development of a CMC strategy and related timelines (including Gantt charts), proactively balances risks against project needs, and communicates progress and related plans in a timely and transparent manner. Presents results and processes chemistry-related matters; manages process chemistry-related activities. Establishes metrics and has accountability for progress against project goals; regularly determines research project deadlines and objectives.

EDUCATION AND EXPERIENCE:
A Ph.D. degree (strongly preferred) in organic chemistry with a focus on total synthesis or methodology development and 3+ years of pharmaceutical industry experience; an MS degree with 9+ years of pharmaceutical industry experience; or a BS degree with 11+ years of relevant pharmaceutical industry experience. Expert understanding of a wide range of synthetic organic chemistry, including reaction mechanistic aspects and synthetic route design (retrosynthetic analysis), paired with excellent laboratory and productivity skills. A high level of proficiency in multi-step synthesis, purification, and characterization of complex organic molecules using the latest techniques. Experience with process research/synthetic route scouting is mandatory and an understanding of the principles of process development is preferred. Experience in the use of technologies (e.g., flow chemistry, photo redox chemistry, Process Analytical Technologies (PAT) such as FT-IR, NIR, FBRM, UV-vis, etc., automation, artificial intelligence, kinetic modeling, etc.) and an interest in application to early-stage development programs is considered a plus. Experience with cGMP production and regulatory requirements is preferred, but not required. Experience in introducing synthetic/manufacturing technologies into a GMP setting and working in a multi-disciplinary team is preferred, but not required.

COMPETENCIES AND SKILLS:
Analytical and Problem-Solving Skills – Ability to troubleshoot critical issues or problems using appropriate information and determine causes and possible solutions. Teamwork – Builds a collaborative network of relationships with people in a variety of functions and roles; and leverages formal and informal networks to accomplish goals. Promotes shared responsibility for getting things accomplished across our organization. Communication Skills – Communicates complex information clearly and engagingly; documents issues and/or concerns concisely with colleagues; asks for and provides the right amount of information to meet the needs of management, direct reports, and project teams; adjusts communication style as appropriate for the audience; proactively and effectively communicates with stakeholders and management; technical writing skills to support authorship and approval of internal technical documents. Technical – Subject matter expertise in one or more specific scientific area(s) of organic chemistry as well as multi-step synthesis of pharmaceutically active ingredients. Resource Management – Ability to manage timelines as well as individual, departmental, and project goals; effective management of internal and external resources (CDMOs). Leadership Skills – Identifies opportunities and demonstrates initiative towards the accomplishment of department/function goals and objectives. Development/Growth – Possesses self-awareness and a learning-oriented mindset with a desire to continually build and grow leadership, management, and technical skills to elevate personal, team, and organizational performance and capabilities.

LOCATION AND TRAVEL REQUIREMENTS:
On-site role in Cambridge, MA. Some domestic and international travel may be necessary. Ability to travel to meetings or external vendor/CDMO sites, including overnight trips. Requires less than 10% travel.

Please contact Darren Gutowski dgutowski@clarkdavis.com