Associate Vice President (AVP) - Peptides Technical Support

Asymchem, Inc

1d•Hybrid

About The Position

A seasoned, established technical professional adept at promoting Asymchem’s broad capabilities to provide a continual pipeline of projects necessary to grow the business while meeting established revenue targets for the company. Additionally, this role utilizes their vast executive level network to bring in new business, provides industry feedback on what Asymchem needs to do differently from a technical perspective. Also, will be tasked with technically supporting the business’ largest accounts by volume and revenue as well as supporting new customers as required. Will need to possess the technical ability necessary but also the ability to effectively build and develop teams and individuals for future growth. This position plays a critical technical and leadership role in the company’s Chemical Macromolecule Development business. It will have direct accountability to develop and grow this sector of the business along with providing the necessary technical consulting ability to C-suite leadership and key functional areas such as Business Development, Manufacturing, and Technical Support.

Requirements

15+ years’ experience in the contract manufacturing industry (CDMO).
PhD. in Chemistry or relatable Life Science focus. with a deep understanding of oligonucleotide peptide, synthetic organic and process chemistry
A thorough understanding of technology transfer and Good Manufacturing Practices is required.
CMMD understanding and experience supporting IND and NDA submissions in the global regulatory climate is required.
Strong project management skills. Experience collaborating with culturally diverse external partners. Ability to support FDA audit and response, due diligence assessment
Must have effective communication skills.
Level level gravitas to manage complex technical, business, and client issues with speed, capability, and ability to manage adequately to the target audience as required.
Demonstrable track record of successful sales of CMC drug substance and/or drug product to the originator (non-generic) biotech/pharma industry.
Well-established network of clients and industry contacts
Strong understanding of clinical and commercial manufacturing space
In-depth knowledge of the pharmaceutical drug development process
Excellent interpersonal, communication and presentation skills. Team player
Basic understanding of Incoterms and GAAP revenue recognition.
Domestic & International Travel as required. Approximately 30%

Nice To Haves

Preference will be given to candidates with experience in both development and manufacturing operations.
Experience in continuous flow and biocatalysis manufacturing techniques is highly desirable
Bilingual English and Mandarin a plus but not required.

Responsibilities

Works with individual project teams, designing and executing long-term plans to improve existing commercial processes. Considers both incremental improvements for improved yield/reduced cost and major new applications of Asymchem technology. Work with corresponding R&D to set up needed laboratory work and with production management for implementation of improvements.
Provides technical support to Asymchem BD with the aim of winning new late phase and commercial opportunities or expanding existing commercial products. This includes steering and approving proposals written by individual technical teams and presenting them to customers. Educate BD about new facilities and capabilities that affect commercial products.
Contributes to the development of new technology within Asymchem.
Working with the affected locations and teams, maintaining and improving company work practices to ensure correct execution of manufacturing, testing, and release of commercial products. These systems (which include vendor qualification, process safety assessments, process validation requirements, change control and risk assessments, and corresponding regulatory assessments must be aligned with expectations from FDA and major customers.
Manages existing and future manufacturing site selection issues for commercial products. One part of this job is assessing the fit of new commercial opportunities for different Asymchem sites and making appropriate recommendations. Also, when required to move a commercial product by changing business conditions such as opening, expansion, repurposing, or closure of an Asymchem site, put together and manage a transition plan covering all aspects of the move, including regulatory updates by the customer. This role will closely cooperate with customers and Asymchem’s corresponding leaders while proactively reporting any escalating issues to Asymchem senior leadership accordingly.
Both directly and indirectly guiding individual project teams, take care of client management for the corresponding Project Clinical Phase and commercial projects. Ensure that internal teams are aligned with the requirements for each project as required.
Provides assistance to the CEO in reviewing and finalizing critical FDA audit documents as required.