Associate II, CMC Operations

Posted 21 Hours Ago
Be an Early Applicant
Waltham, MA, USA
Hybrid
78K-95K Annually
Mid level
Biotech • Pharmaceutical
The Role
Supports analytical CMC program management across multiple pharmaceutical development projects. Responsibilities include coordinating vendors, tracking analytical documents, deliverables, timelines, contracts, invoices, budgets, and CMC tracking tools. The role communicates cross-functional issues, escalates risks, and manages relationships with external partners. Success requires pharmaceutical drug development experience, cross-functional collaboration, strong communication, problem-solving, and a bachelor's degree.
Summary Generated by Built In

At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera’s mission to advance novel therapies for obesity and related conditions.
 
We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence. As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team.

What You’ll Do:

Reporting to the Associate Director, CMC Operations, the Associate II, CMC Operations will support the flawless execution of Kailera’s analytical CMC program management activities. The individual will collaborate with CMC core team representatives and bridge cross-functional CMC sub-teams to manage all analytical activities and timelines for Kailera’s multiple development projects.


Required location: Waltham, MA (hub-based, onsite 3-4 days per week)


Responsibilities:

  • Participate in vendor meetings and track and manage analytical documents and deliverables
  • Support analytical CMC activities by tracking and monitoring vendor progress to ensure all work is occurring according to the contracted scope and schedule; work closely with analytical team to ensure invoices are submitted accurately
  • Assist with CMC analytical program budget by reviewing contract progress and scope and alerting the appropriate analytical teams of potential contract changes not captured in the current agreed to contracts
  • Support the Associate Director, CMC Operations by maintaining and updating appropriate CMC tracking tools, proactively communicating key issues and other critical topics, and escalating concerns in a timely manner
  • Assists in managing relationships and communication between Kailera and external partners or service providers as required

Required Qualifications:

  • 2-5 years of experience in pharmaceutical drug development and track record of success supporting multiple projects or programs simultaneously
  • Excellent communication skills
  • Proven track record of creativity, problem solving, and productivity
  • Demonstrated success working in interdisciplinary and cross-functional teams
  • Comfortable working in a dynamic, interactive, fast-paced, and entrepreneurial environment

Education:

  • Bachelor’s degree
    • scientific discipline preferred
Salary Range
$78,000$95,000 USD

For Full Time Roles: This range represents the company’s good-faith estimate of the salary at the time of posting. Actual pay may vary based on experience, skills, qualifications, location, and internal equity. We also offer comprehensive health coverage, flexible time off, paid holidays, and a year-end shutdown. Enjoy a monthly wellness stipend, generous 401(k) match, tuition reimbursement, commuter benefits, disability and life insurance, plus annual bonus opportunities and equity grants—because your well-being and future matter to us.

EQUAL EMPLOYMENT OPPORTUNITY INFORMATION: 

Kailera Therapeutics, Inc. is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race (including traits historically associated with race, such as hair texture and protective hairstyles), color, creed, religion (including religious dress and grooming practices), national origin, ancestry, citizenship status, age (40 and over), sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, reproductive health decisions, domestic victim status, political affiliation, or any other characteristic protected by applicable federal, state, or local laws and ordinances.

E-Verify:

Kailera Therapeutics, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires.

 #LI-Hybrid

Skills Required

  • 2-5 years of experience in pharmaceutical drug development
  • Track record of supporting multiple projects or programs simultaneously
  • Excellent communication skills
  • Creativity, problem-solving, and productivity
  • Experience working successfully in interdisciplinary and cross-functional teams
  • Ability to work in a dynamic, interactive, fast-paced, entrepreneurial environment
  • Bachelor's degree
  • Bachelor's degree in a scientific discipline
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The Company

What We Do

Kailera is an advanced clinical-stage biotechnology company focused on obesity care. It is developing a diversified pipeline of GLP-1 therapies and other obesity-management medications intended to provide treatment options for people living with obesity across their treatment journeys. The company’s team has experience developing and commercializing therapies for metabolic diseases, and its clinical-stage candidates use multiple GLP-1 mechanisms and routes of administration.

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