Senior Director to Vice President, CMC

Reference: BH-170073

Position Summary：

Oversee the CMC activities of the company under the supervision of the CEO
Drive the execution of the CMC projects throughs CRO and CDMOs to meet critical timeline and global quality standard.
Lead the internal development of drug candidates, drug substances and drug products of the company and build the infrastructure and function team to substantiate it
Collaborate closely with drug discovery team, regulatory team and clinical team to ensure smooth execution of projects
Represent the company at conferences, meetings, conventions and other events as CMC representative

Responsibilities:

Responsible for providing technical leadership and guidance across CMC development disciplines to all outsourced development and manufacturing activities by providing clear objectives for multiple CDMO partners, assess all experimental plans and results, and coordinate future work to achieve desired development and manufacturing expectations
Scope of technical responsibilities include pre-formulation, formulation development, analytical method development and transfer, process development, optimization, scale-up studies/technology transfer, clinical manufacturing, and stability studies
Build collaborative relationships across functional areas to translate research and clinical program objectives into aligned, clear, and fit-for-purpose CMC objectives, milestones, timelines, resources and budgets
Develop strong relationships with external CDMO partners to establish and manage appropriate scopes of work, and to ensure all activities are within program expectations
Provide succinct and pertinent communication of program CMC status, priorities and pending activities, verbal and written, across company functional areas and to senior leadership
Support, in collaboration with Quality and Regulatory, selection of strategic CDMO, manufacturing, analytical, and packaging partners, initially focused on early-stage programs. Negotiate, obtain and review for accuracy legal and corporate approval for service agreements and related statements of work for development activities with external partners
Direct/oversee contract manufacturing, testing, packaging and labeling operations for the company’s drug substances and drug products, and ensure timely clinical drug supply for global trials.
Actively manages CMC aspects of IND submissions and other regulatory interactions for relevant products in close collaboration with the involved departments. Author and/or review high-quality CMC documentation for Health Authority submissions, establishing and applying CMC global regulatory strategies. Ensure technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements.

Qualifications:

PhD in Pharmaceutics or related disciplines
10+ years of experience in pharmaceutical or biotechnology CMC management of development programs
Broad understanding of all aspects of CMC including process development, regulatory and quality requirements, analytical development, formulation and drug product technologies, distribution across multiple regions
Extensive experience in managing CDMOs in different regions for the manufacture of cGMP drug substance and drug product
Experienced with cGMP manufacturing and IND filings; good working knowledge of relevant US FDA, EMEA and China regulations
Proven track record of superior interpersonal and communication skills with ability to develop strong positive relationship with senior management as well as all levels of the organization
Ability to operate effectively within an entrepreneurial and science-driven company environment; self-motivated, delivery-oriented, assertive, able to inspire others, driven and hands-on with unquestionable integrity and the highest ethical standards
Proven experience in managing teams, budgets and resources
Project management skills
Proven ability for strategic thinking in a complex business environment
Ability to deal with ambiguity
Mentorship, innovative thinking, keen industry insight, strong analysis and problem solving

BeathChapman Pte Ltd
Licence no. 16S8112

Ethos BeathChapman is a global group of executive recruitment experts in Asia, Australia and EMEA, with a network beyond. We connect the world's exceptional companies to exceptional people.

Connect with us at www.ethosbc.com

Add your CV and application details

No CV attached... *

First name *

Last name *

Enter your email address *

Phone number *

Employment Status *

NRIC / FIN number - This data is collected for mandatory submission to Singapore's Ministry of Manpower for roles located in Singapore. Indicate NA if you do not have an NRIC or FIN number *

Kindly refer to clause 5a and 5b (i) of the Ministry of Manpower's Employment Agencies Licence Conditions to understand how your NRIC / FIN number will be used. This data will not be provided to employers.

I have read and accept the privacy policy

Apply: Senior Director to Vice President, CMC

Company Background:

Add your CV and application details