Senior Business Consultant Pharma Cmc

7 days ago

East Coast, Singapore Diverse Lynx Full time

**Job Title: Senior Business Consultant Pharma CMC***
**Location : East Coast TCS locations***
**Travel: 25%***

**Experience: 14+***

1. 15+ years of experience with pharma pre-clinical and clinical labs and relevant data management, biostatistical analysis, regulatory affairs
2. 10+ Years of experience with industry standard processes and solutions for CMC in labs direct FDA/EU regulatory experience is required. Experience with guidelines e.g. ICH is required.
3. Experience with solid and liquid dosage forms and across large and small molecules is required
4. Proven project and program management experience with end to end responsibility a plus. Processes to include pre-formulation and formulation studies, analytical methods design, ICH stability and compatibility, and dosage form design.
5. Strong technical writing, presentation and articulation skills; Excellent communication on the ways technology is deployed in pharma manufacturing and supply chain
6. Ability to lead with the client digital transformation team; contribute to proposal developments
7. Hands on experience with at least one analytical environment
8. Experience of presenting solution design with customer clinical/scientific/technical stakeholders, driving business analyst process like requirement specification, functional requirement to technical requirement transformation and documentation
9. Develop and maintain relationship with target and client executives
10. Coordinate development activities collaboratively with customer teams and offshore teams
11. Collaborate with organization sales team on providing proposed solution and architecture for pre-sales discussions in areas of pharma labs
12. Ability to lead and coach technical and business development team
13. Collaborate in identifying, assessing, and selecting innovative ideas from internal and external sources based on their value proposition
14. Ability to work collaboratively with global delivery team
15. Self-motivated person with moderation and persistence skills

**Responsibilities**:
1. Lead solution design with customer clinical/scientific/technical stakeholders, driving business analyst process like requirement specification, functional requirement to technical requirement transformation and documentation for pharma labs
2. Bring solid executive presence and domain expertise for supply chain, manufacturing; clinical data management, biostatistical analysis, regulatory affairs or pharmacovigilance a plus
3. Develop and maintain relationship with target and client executives
- Diverse Lynx LLC is an Equal Employment Opportunity employer. All qualified applicants will receive due consideration for employment without any discrimination. All applicants will be evaluated solely on the basis of their ability, competence and their proven capability to perform the functions outlined in the corresponding role. We promote and support a diverse workforce across all levels in the company._

  • Senior Business Consultant Pharma Cmc

    1 week ago

    East Coast, Singapore Diverse Lynx Full time

    **Experience: 14+** 1. 15+ years of experience with pharma pre-clinical and clinical labs and relevant data management, biostatistical analysis, regulatory affairs 2. 10+ Years of experience with industry standard processes and solutions for CMC in labs direct FDA/EU regulatory experience is required. Experience with guidelines e.g. ICH is required. 3....

  • Senior Business Consultant

    2 weeks ago

    East Coast, Singapore Emonics, LLC Full time

    **Position**:Senior Business Consultant** **Location***: **East Coast (Travel: 25%)** **Duration***: **Fulltime Position** **Job Description: - ** **Technical/Functional Skills** **-** **Experience-14+ years** - 15+ years of experience with pharma pre-clinical and clinical labs and relevant data management, biostatistical analysis, regulatory affairs -...

  • Business Consultant Pharma Labs

    1 week ago

    East Coast, Singapore Diverse Lynx Full time

    1. 7+ years of experience with pharma pre-clinical and clinical labs and relevant data management, biostatistical analysis, regulatory affairs 2. 3+ Years of experience with industry standard software for supply chain in pharma, medtech or provider space 3. Strong technical writing, presentation and articulation skills; Excellent communication on the ways...

  • Business Consultant Manufacturing

    1 week ago

    East Coast, Singapore Diverse Lynx Full time

    **Experience: 7+** 1. 5+ years of experience with pharma manufacturing with clinical data management, biostatistical analysis, regulatory affairs or pharmacovigilance; if pharmacovigilance background, then familiar with enabling technologies like Veeva, Argus, Arisg, etc; if data management background, then experience in documenting, verifying, validating...

  • Business Consultant Digital Health

    1 week ago

    East Coast, Singapore Diverse Lynx Full time

    **Experience: 7+** 2. 3+ Years of experience with industry standard software for digital health in pharma, medtech or provider space 3. Strong technical writing, presentation and articulation skills; Excellent communication on the ways technology is deployed in pharma or medtech digital health 4. Ability to interface with the digital transformation team;...

  • Senior Manager

    5 days ago

    East Coast, Singapore Autolus Ltd Full time

    With a significantly expanding regulatory team, an exciting opportunity has arisen for an experienced CMC Regulatory Affairs Associate Director to join the Autolus team to work on innovative and pioneering products across Autolus’ cell and gene therapy portfolio. The Regulatory Affairs Associate Director will be part of the CMC regulatory affairs team with...

  • Vp, Head of Business Architecture

    4 days ago

    East Coast, Singapore HopHR Full time

    We're looking for an expert in drug development architecture and translating business needs and processes into an actionable roadmap to join a Top Pharma company with an exponential growth journey This person will help define and lead technical decisions within drug development, bringing deep technical and strategic experience within a drug development...

  • Manager of Business Development

    2 weeks ago

    East Coast, Singapore Global Life Science Hub Full time

    Location: East Coast, USA Global Life Science Hub represents a market-leading Contract Development and Manufacturing Organization (CDMO). This position is for a Manager of Business Development, East Coast, which is a remote role requiring residence in the US Northeast region. The Manager of Business Development will be responsible for implementing...

  • Automation Consultant

    2 days ago

    East Coast, Singapore Concept Resourcing Full time

    **Automation Consultant - RPA/IPA - United States - Remote** **$90-100k + package** Concept International are looking for an Automation Consultant to join a fast-growing tech company focused on intelligent process automation for mid-market clients. The role will support the acquisition of new business through post-sales customer presentations, product...

  • Data Solution Architect

    13 hours ago

    East Coast, Singapore Epista Life Science Full time

    At **Epista**, we are redefining what excellence looks like in the life science industry. As trusted advisors to some of the world’s leading pharma, biotech, and medtech companies, we combine regulatory insight with deep domain expertise to drive performance. Our mission? To **define and deliver process, technology, and compliance excellence**—empowering...