Job details

CMC Chemistry Director

Enveda is looking for a CMC Chemistry Director to join our team remotely!

The contribution you will make:

As CMC Chemistry Director, you will play an important role in the execution of Enveda Biosciences’ chemical and pharmaceutical development and manufacturing initiatives. Your expertise will guide the CMC-related activities spanning process development, manufacturing, analytical development, and regulatory submissions. As a key figure in the CMC team and reporting directly to the VP, CMC, your contributions will be instrumental in the execution of our development manufacturing strategies and ensuring the delivery of high-quality products to the market.

You get to collaborate on:

Contribute to the development and oversight of the budget for your projects, emphasizing cost-effectiveness without compromising quality.
Collaborate cross-functionally with R&D and Quality Assurance to ensure regulatory compliance and seamless implementation of CMC standards and cGMP regulations.
Manage and oversee the process design and troubleshooting, scale-up, and tech transfer for drug substances and product manufacturing, collaborating with both external contract development and manufacturing organizations (CDMOs) and internal development project teams to deliver drug substance and clinical drug product according to established timelines.
Ensure strict adherence to global regulatory guidelines throughout the manufacturing, packaging, testing, and distribution processes.
Serve as a CMC point of contact during discussions with health authorities worldwide, as needed.
Lead the preparation and critical review of CMC regulatory documents for IND, QOS, IMPD and various other regulatory submissions, as needed.
Oversee drug product supply chain for clinical trials, ensuring timely and efficient delivery.

Who will thrive in this role?

A Ph.D. or equivalent in Synthetic Organic Chemistry or Chemical Engineering.
A minimum of 10 years experience in pharmaceutical CMC development.
Experienced in chemical development, manufacturing and tech-transfer with a solid understanding of cGMP regulations.
Experienced in the management and oversight of development and manufacturing projects conducted at external CDMOs.
Experienced in the preparation and review of CMC regulatory documents
Leaders with a deep understanding of the latest technology trends in CMC and the ability to integrate these into development and manufacturing activities.
Creative thinkers with demonstrated problem-solving ability.
Good communicators capable of conveying complex scientific data, both orally and in writing, to a broad audience, including non-specialists and regulatory bodies.
Experienced in managing CMC budgets at the project level.
If you don't meet all of the requirements listed here, we still encourage you to apply. No job description is perfect, and we might find an even more suitable opportunity that matches your experience.

What to expect in the interview process:

HR Screen (30 minutes)
Hiring Manager Interview (45 minutes)
Work Sample Interview (45 minutes)
Enveda Culture Interview (30 minutes)
Technical Interview (60 minutes)

Some of the total rewards of working here

Culture: Enveda lives for people
Salary: $225,000 - $245,000
Equity
Healthcare: Medical, dental and vision insurance. Company pays 90% of the premium for employee and dependents.
401k: Traditional or Roth 401k matching of 4% (100% of your contributions up to 4% of your annual compensation).
PTO: Flexible paid time off (that we encourage and celebrate). Company-wide weeklong break to recharge. 10 observed holidays.
Work-Life Harmony
Adoption Assistance: At Enveda we want to celebrate and support employees who want to adopt children. We're excited to offer adoption assistance to employees who have completed the adoption process, including placement.

Come join us!

Our employees are the lifeblood of our work and our inspiration to press on. Together we've built a special place here—a drug discovery platform that's unique in the world with an incredible team collaborating in a creative, transformative culture. Our mission is to bring hope to patients everywhere. Our progress towards that goal would not be possible without talented people like you.

Employee Promise

Using our imagination and dedication, we are working to improve human health and give hope to patients everywhere. Our work together is empowering, trustable and collaborative, enabling you to do your best work.

Enveda's values

Curiosity: Learn and challenge.

Agency: Own and initiate.

Journey: Love the process.

Charity: Take care of each other.

Unity: We are one Enveda.

We value your uniqueness

One of life's gifts is to interact with a variety of people. Each of us has a unique story that shapes how we view the world, and solve problems. Learning from each other enhances our collective wisdom while achieving better outcomes at a faster clip. People from all kinds of backgrounds can succeed in all kinds of roles.

Our work environment appreciates the contributions of every person. Working together is how we produce results that illuminate our Purpose - To Deliver Hope To Every Patient. Unity is a company value because success depends on trusting, working relationships that respect the commonality and differences of people.

At Enveda we are building a place where every person can do the best work of their lifetime.

Enveda is an equal opportunity employer. We do not discriminate on the basis of characteristics protected by federal, state or local laws.

*Please note jobs may be taken down from our website, this does not mean they have been filled. This is to maintain our candidate experience for current applicants. If you are in the interview process and would like to request a copy of the job description, reach out to your recruiting contact.

Average salary estimate

$235000 / YEARLY (est.)

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$225000K

$245000K

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What You Should Know About CMC Chemistry Director, Enveda

Enveda is seeking a passionate CMC Chemistry Director to join our innovative team, working remotely from Boulder, CO! In this pivotal role at Enveda Biosciences, you will spearhead our chemical and pharmaceutical development initiatives, ensuring our projects not only meet but exceed regulatory standards and quality expectations. Your expertise will be essential in navigating the complexities of process development and manufacturing, analytical development, and regulatory submissions as you report directly to the VP of CMC. Collaborating with R&D and Quality Assurance, you'll contribute to project budgets focused on cost-effectiveness and quality. You’ll lead the design and execution of scale-up processes, partnering with both external CDMOs and our internal teams to ensure timely delivery of drug substances. As the point of contact during health authority discussions, your role is vital in preparing and reviewing critical CMC regulatory documents. Our ideal candidate has a Ph.D. or equivalent in Synthetic Organic Chemistry or Chemical Engineering, accompanied by at least a decade of experience in pharmaceutical CMC development. Your strong understanding of cGMP regulations, along with your creative problem-solving abilities and excellent communication skills, will set you apart. If you’re ready to make a meaningful impact in drug discovery and contribute to our mission of delivering hope to patients everywhere, we want to hear from you! Join us to not only build a successful career but also to be part of a unique culture that celebrates curiosity, agency, and unity.

Frequently Asked Questions (FAQs) for CMC Chemistry Director Role at Enveda

What are the primary responsibilities of a CMC Chemistry Director at Enveda?

As a CMC Chemistry Director at Enveda, your primary responsibilities will include overseeing the chemical and pharmaceutical development processes, managing CMC-related activities encompassing process development, manufacturing, and regulatory submissions, and ensuring strict adherence to compliance regulations. You’ll also lead the preparation of key regulatory documents and serve as a liaison with health authorities.