CMC Project Leader

Job Description

Job Description

Job Title

Associate Director / Senior Manager, CMC Project Management

Location

Boston area preferred (or ability to commute regularly)

Company Overview

Hongene Biotech is a global leader in nucleic acid manufacturing, supporting RNA therapeutics, mRNA vaccines, and molecular diagnostics. With a vertically integrated platform from raw materials to CDMO services, we enable our partners to accelerate development with efficiency and quality.

Position Overview

This role will report directly to the VP, Global Head of CMC & Regulatory and is critical in strengthening Hongene’s project management capabilities for its oligonucleotide contract manufacturing services.

Level and title will be determined based on experience. We are primarily targeting Senior Manager to Associate Director level. Exceptional candidates may be considered at Director level.

The Primary Job Responsibilities

1) Drive project management efforts associated with CMC activities to support oligonucleotide contract manufacturing projects at Hongene Biotech.

2) Support Head of CMC and Oligonucleotide team in developing and executing development and manufacturing strategy and tactical executional plans.

3) Bridge communication between Clients and the internal teams in support of multiple contract manufacturing projects for different clients, including participation in technical calls, tracking of action items and facilitating rapid decision making within the team to drive programs forward.

4) Coordination with AD/PD, manufacture, quality and BD team to build, and manage global clients’ project timelines, work with BD to generating RFP proposals and evaluate necessary resources and ensure RFP proposals are aligned with overall strategy and cost estimation. Proactively identify potential risks, resourcing constraints and conflicts that could impact project timelines; collaborate with the AD/PD, manufacturing, QA/QC teams to develop appropriate solutions.

5) Support projects with strategic partners in US.

The candidate must have strong communication skills and be capable of strategically communicating with internal and external stakeholders, as well as effectively communicating across functions and fluent speaking both English and Mandarin. Finally, the candidate must be comfortable with, and thrive in, a fast-paced entrepreneurial environment.

Minimal Requirements

• B.S or M.S in Pharmaceutical Science, Chemistry, Biochemistry, or related scientific discipline with 8+ years of applicable experience in the biotechnology or pharmaceutical industry.

• Demonstrated proficiency in the discipline of project management. Experience with operating in a GMP environment and working in cross functional environments. Demonstrated ability to exercise independent judgement and strategic thinking.

• Strong interpersonal skills and experience of managing cross-function projects.

• Ability to thrive in a fast-paced, hands-on research and development environment.

• Adept at building strong relationships and collaborating with colleagues at all levels.

• Ability to discern paths forward within ambiguous environments.

• Excellent verbal, written, and presentation skills for communication with internal and external customers is essential.

Preferred Qualifications

• Minimum of 5 years’ experience in project or program management at a biotechnology or pharmaceutical company with direct involvement in the CMC area

• Experience with project management tools (e.g. MS Project, Smartsheet, Clarizen) and collaboration tools (BOX, SharePoint, MS Teams)

• Understanding of the different phases of drug development and cGMP requirements

• Experience in small molecules, oligonucleotides, or biologic drug development

• Located in US EST time zone