CrawlJobs Logo

Associate Director, CMC Operations

kailera.com Logo

Kailera Therapeutics

Location Icon

Location:
United States , Waltham

Category Icon
Category:
Research and Development

Job Type Icon

Contract Type:
Not provided

Salary Icon

Salary:

160000.00 - 200000.00 USD / Year
Save Job
Save Icon
Apply Position

Job Description:

Manage the flawless execution of Kailera’s CMC activities, spanning departmental financial management, alliance management with CDMO partners, technical development work, technology transfers, manufacturing, and preparation of regulatory submissions. Support cross-functional CMC sub-teams to manage all technical activities for Kailera’s multiple development projects. Establish preparation and monitoring of departmental budgets.

Job Responsibility:

  • Support execution of CMC-related projects, culminating in the successful preparation of regulatory submissions and product approvals
  • Actively support Tech Ops strategies and goals by participating in and/or leading cross-functional CMC sub-teams
  • Work closely and collaboratively with Tech Ops, Quality, Regulatory, and Finance colleagues to maintain highly efficient practices for pharmaceutical product development and budget management activities
  • Proactively communicate key issues and any other critical topics in a timely manner to the appropriate management level and/or to any other relevant project team members
  • Ensure quality, quantity, and timelines in all assigned projects
  • Update team members on project target dates and priorities. Proactively contributes to budget forecasts and tracking expenses

Requirements:

  • 10+ years of experience in pharmaceutical drug development, clinical and/or commercial manufacturing familiarity, and track record of success supporting multiple projects or programs simultaneously
  • Excellent communication/presentation skills and proficiency in Smartsheet software
  • Proven track record of creativity, problem solving, and productivity, particularly when no or minimal precedent is in place
  • Demonstrated successful experience with working in interdisciplinary and cross-cultural teams
  • Bachelor’s degree in a scientific discipline preferred
What we offer:
  • comprehensive health coverage
  • flexible time off
  • paid holidays
  • year-end shutdown
  • monthly wellness stipend
  • generous 401(k) match
  • tuition reimbursement
  • commuter benefits
  • disability and life insurance
  • annual bonus opportunities
  • equity grants

Additional Information:

Job Posted:
January 15, 2026

Employment Type:
Fulltime
Work Type:
Hybrid work
Icon
Kailera Therapeutics - All Job Offers
Job Link Share:
Copy Link Icon
Facebook Icon Twitter Icon LinkedIn Icon

Looking for more opportunities? Search for other job offers that match your skills and interests.

Briefcase Icon

Similar Jobs for Associate Director, CMC Operations

Director, Product Quality Leader

This individual will serve as a technical quality expert for one or more product...
Location
Location
United States
Salary
Salary:
164000.00 - 225500.00 USD / Year
biomarin.com Logo
BioMarin Pharmaceutical
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • BA/BS in life sciences or related field required
  • Advanced degree desirable
  • 12+ years of experience with Biotechnology, Pharmaceutical, Medical Device or other, highly regulated, industry
  • Preferred experience in biologics product development and licensure or technical support
  • Experience in both clinical and commercial phases of product lifecycle is highly desirable
  • Experience supporting combination products across clinical and commercial stages, including device quality considerations, is a plus
  • Excellent interpersonal and communications skills
  • Demonstrated strong leadership capability
  • Experience with influencing diverse stakeholders and driving accountability and decision-making in a highly matrixed, cross-functional environment
  • Highly capable of building strong, effective working teams
Job Responsibility
Job Responsibility
  • Serve as a technical quality expert for one or more products during clinical development through post-commercialization
  • Make technical quality-related decisions
  • Serve as the single point of contact on the CMC team for all quality functions, risks and issues
  • Provide efficient and effective quality leadership of CMC-related strategic activities
  • Drive associated quality decisions
  • Participate fully in CMC team meetings and other relevant technical forums
  • Partner with CMC Team and the Quality organization to identify, develop and prioritize long-term product strategies/initiatives
  • Accountable for creation of the product-specific Quality strategy
  • Lead the cross-functional Quality Partner Team (QPT) supporting Quality-related CMC deliverables
  • Own and manage the product quality risk register
What we offer
What we offer
  • Discretionary annual bonus
  • Discretionary stock-based long-term incentives
  • Paid time off
  • Company-sponsored medical, dental, vision, and life insurance plans
  • Fulltime
Read More
Arrow Right

Director, CMC and Device Regulatory Affairs

The Director, CMC and Device Regulatory Affairs will lead the implementation of ...
Location
Location
Salary
Salary:
220000.00 - 240000.00 USD / Year
apogeetherapeutics.com Logo
Apogee Therapeutics
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Advanced degree in Chemistry, Pharmaceutical Sciences, Biochemistry, or a related field
  • Minimum of 10 years of industry experience
  • At least 6 years in CMC regulatory for biologics and/or drug-delivery combination products
  • Experience with late-stage development (Phase 3) and/or BLA/MAA/Notified Body submissions preferred
  • Proven track record of leading cross-functional submission teams and successful regulatory submissions
  • Strong knowledge of global regulatory requirements (FDA, EMA, ICH)
  • Excellent communication, leadership, and project management skills
  • Detail-oriented with ability and desire to work in a fast-paced, nimble, hands-on, team-oriented, biotech environment
  • Up to 15 – 20% travel is required, including mandatory in-person attendance at Apogee All Hands meetings typically held twice per year
  • Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient, and Egoless
Job Responsibility
Job Responsibility
  • Develop and implement global CMC and device regulatory strategies for assigned program(s)
  • Lead the preparation and review of CMC and device regulatory submissions (e.g., INDs, CTAs, BLAs, MAAs, Notified Body submissions)
  • Collaborate with Technical Operations, Quality, Clinical, and Regulatory teams to ensure regulatory requirements are integrated into product development plans
  • Identify regulatory risks associated with product development and propose mitigation strategies
  • Manage interactions with regulatory agencies and notified bodies, including meeting preparation and responses to queries
  • Review CMC-related changes for potential impact on global submissions, provide regulatory impact assessments, and work with project teams to ensure timely reporting of changes
  • Archive and maintain regulatory submissions and correspondences in Apogee’s regulatory information management system
  • Contribute to the optimization and implementation of processes and procedures, commensurate with departmental and company growth
What we offer
What we offer
  • Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
  • Three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave
  • Commitment to growing you professionally and providing access to resources to further your development
  • Apogee offers regular all team, in-person meetings to build relationships and problem solve
  • Fulltime
Read More
Arrow Right
New

Primary Teaching Assistant

Are you passionate about shaping young minds? As a Teaching Assistant in primary...
Location
Location
United Kingdom , Caterham
Salary
Salary:
Not provided
https://www.randstad.com Logo
Randstad
Expiration Date
May 22, 2026
Flip Icon
Requirements
Requirements
  • communication
  • teaching assistant experience
  • passionate
  • positive
  • flexible
  • hold two work references
  • UK work eligibility
Job Responsibility
Job Responsibility
  • providing crucial support to the class teacher
  • working with a child one-on-one or in small groups
  • preparing the classroom and aiding in the learning process
What we offer
What we offer
  • Convenient Mobility: Ideal for drivers due to diverse school locations
  • Versatile Exposure: Work across various schools for diverse experiences
  • Weekly Pay: Enjoy hassle-free weekly payments with fantastic daily rates
  • Effortless Hours: Submit your hours seamlessly through our time sheet app
  • Rewards Await: Earn £300 through our Refer a Friend scheme
  • Dedicated Support: Benefit from a consultant deeply connected with supported schools
  • Personalised On boarding: Receive tailored assistance for compliance
  • Compliance Assistance: Support for DBS on the update service or help to obtain one
  • career
  • work-life
  • Fulltime
Read More
Arrow Right
New

Primary Teaching Assistant

Are you passionate about shaping young minds? As a Teaching Assistant in primary...
Location
Location
United Kingdom , Caterham
Salary
Salary:
Not provided
https://www.randstad.com Logo
Randstad
Expiration Date
May 21, 2026
Flip Icon
Requirements
Requirements
  • Non Teaching
  • communication
  • teaching assistant experience
Job Responsibility
Job Responsibility
  • Providing crucial support to the class teacher
  • Working with a child one-on-one or in small groups
  • Preparing the classroom
  • Aiding in the learning process
What we offer
What we offer
  • Convenient Mobility: Ideal for drivers due to diverse school locations
  • Versatile Exposure: Work across various schools for diverse experiences
  • Weekly Pay: Enjoy hassle-free weekly payments with fantastic daily rates
  • Effortless Hours: Submit your hours seamlessly through our time sheet app
  • Rewards Await: Earn £300 through our Refer a Friend scheme
  • Dedicated Support: Benefit from a consultant deeply connected with supported schools
  • Personalised On boarding: Receive tailored assistance for compliance
  • Essential Traits: Be passionate, positive, flexible, and hold two work references
  • Compliance Assistance: Support for DBS on the update service or help to obtain one, and UK work eligibility
  • Fulltime
Read More
Arrow Right
New

Long term supply teacher

Transform lives through education as a caring and dedicated teacher, making a la...
Location
Location
United Kingdom , Caterham
Salary
Salary:
Not provided
https://www.randstad.com Logo
Randstad
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • QTS/PGCE qualification required
  • comprehensive working history and two recent working references
  • DBS on the update service or readiness to obtain one
  • eligibility to work in the UK
  • passion and positivity for teaching
  • good communication skills
  • key stage 1 experience
Job Responsibility
Job Responsibility
  • Full teaching responsibilities within your placement
  • marking, planning, and teaching throughout extended periods
  • payment to scale for placements surpassing 6 weeks
  • full-time availability dedicated to teaching
What we offer
What we offer
  • Refer a friend bonus scheme
  • weekly pay with competitive daily rates
  • simple hour submissions through user-friendly app
  • £300 Refer a Friend bonus
  • dedicated consultant
  • personalised assistance for compliance and seamless onboarding
  • career
  • work-life
  • Fulltime
Read More
Arrow Right
New

Supply Sen Teaching Assistant

Are you passionate about shaping young minds? As a Teaching Assistant in primary...
Location
Location
United Kingdom , Caterham
Salary
Salary:
Not provided
https://www.randstad.com Logo
Randstad
Expiration Date
May 21, 2026
Flip Icon
Requirements
Requirements
  • Non Teaching
  • 121 teaching experience
  • communication
  • SEN experience
  • teaching assistant experience
What we offer
What we offer
  • Career
  • Work-Life balance
  • Refer a friend bonus scheme
  • Dedicated support
  • Personalised onboarding
  • Compliance assistance
  • Fulltime
Read More
Arrow Right
New

Primary Teaching Assistant

Are you passionate about shaping young minds? As a Teaching Assistant in primary...
Location
Location
United Kingdom , Caterham
Salary
Salary:
Not provided
https://www.randstad.com Logo
Randstad
Expiration Date
May 21, 2026
Flip Icon
Requirements
Requirements
  • communication
  • teaching assistant experience
  • Non Teaching
  • passionate
  • positive
  • flexible
  • hold two work references
  • UK work eligibility
Job Responsibility
Job Responsibility
  • providing crucial support to the class teacher
  • working with a child one-on-one or in small groups
  • preparing the classroom and aiding in the learning process
What we offer
What we offer
  • Refer a friend bonus scheme
  • Convenient Mobility
  • Versatile Exposure
  • Weekly Pay
  • Effortless Hours
  • Rewards Await £300 through Refer a Friend scheme
  • Dedicated Support
  • Personalised On boarding
  • Compliance Assistance
  • training and education
  • Fulltime
Read More
Arrow Right
New

Primary Teaching Assistant

Teaching Assistant in Caterham "Supporting student's journeys to success with c...
Location
Location
United Kingdom , Caterham
Salary
Salary:
Not provided
https://www.randstad.com Logo
Randstad
Expiration Date
May 22, 2026
Flip Icon
Requirements
Requirements
  • A genuine passion for education and supporting student development
  • Excellent communication and interpersonal skills
  • The ability to work effectively as part of a team
  • Previous experience working with children or in an educational setting is desirable
Job Responsibility
Job Responsibility
  • Assisting with classroom activities and lesson preparations
  • Providing one-on-one support to students who require additional help
  • Helping to maintain a positive and inclusive learning environment
  • Work with small groups completing activities
What we offer
What we offer
  • Competitive salary based on qualifications and experience
  • Opportunities for professional development and training
  • A supportive and collaborative work environment
  • The chance to make a real difference in the lives of young learners
  • Term time only working
  • Weekly pay with competitive rates of pay
  • Refer a friend bonus scheme
  • Fulltime
Read More
Arrow Right