Associate Director, CMC Operations Job at Kailera Therapeutics (Waltham)

Associate Director, CMC Operations

Reporting to the Senior Director, CMC Operations, the Associate Director, CMC Op...

Location

United States , San Diego

Salary:

160000.00 - 200000.00 USD / Year

Kailera Therapeutics

Expiration Date

Until further notice

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

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

What we offer

Comprehensive health benefits and tax-advantaged savings accounts
Flexible time off, 13 paid holidays, and a companywide year-end shutdown
Monthly wellness stipend
Generous 401(k) match
Disability and life insurance

Fulltime

Associate Director, Drug Product Manufacturing and Development (Oral)

The Associate Director, Drug Product will support drug product activities with e...

Location

United States , San Diego

Salary:

160000.00 - 200000.00 USD / Year

Kailera Therapeutics

Expiration Date

Until further notice

Requirements

10+ years of experience in the pharmaceutical industry with a proven track record of technical expertise in unit operations common to solid oral dosage form (e.g., dry granulation, compression and film-coating)
Extensive experience with management and oversight of activities at CDMO’s
Strong troubleshooting skills with the ability to quickly provide input in a fast-paced environment
Strong working knowledge of Excel, Word, PowerPoint
Experience drafting CMC documents for regulatory filings
Experience using quality systems such as Veeva to author and approve documents
Excellent verbal, written and interpersonal skills
Innovative team-player capable of working cross-functionally to achieve program goals
Ability to travel up to 20% (domestic and international)
Bachelors Degree in Engineering, Pharmaceutical Sciences, Life Sciences or closely related field

Job Responsibility

Contribute to the selection, engagement, and management of CDMO’s, including assessment of capabilities, drafting requests for proposals, and providing recommendations based on selection criteria
Coordinate technology transfer, formulation and process development, optimization, scale-up and manufacturing of clinical supplies, acting as Kailera’s person-in-plant for activities critical to program success
Collaborate closely with internal cross-functional teams, including Drug Substance, Analytical Development, Supply Chain, Clinical, Quality Assurance, and Regulatory Affairs to ensure seamless progression of projects
Review master batch records and executed batch records to ensure product quality
Manage cGMP change controls and manufacturing deviations as necessary, working closely with Kailera’s quality group
Lead initiatives to enhance manufacturing efficiency, reduce costs and improve product quality through experimental design with a focus on commercial preparedness
Author, review, and update CMC specific documents to support worldwide regulatory submissions (i.e., IND, IMPD and NDA)

What we offer

Comprehensive health benefits and tax-advantaged savings accounts
Flexible time off, 13 paid holidays, and a companywide year-end shutdown
Monthly wellness stipend
Generous 401(k) match
Disability and life insurance

Fulltime

Director, Product Quality Leader

This individual will serve as a technical quality expert for one or more product...

Location

United States

Salary:

164000.00 - 225500.00 USD / Year

BioMarin Pharmaceutical

Expiration Date

Until further notice

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

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

Discretionary annual bonus
Discretionary stock-based long-term incentives
Paid time off
Company-sponsored medical, dental, vision, and life insurance plans

Fulltime

New

Associate Director, Global Supply Chain

The Associate Director, Global Supply Chain reports to the Senior Director, Glob...

Location

United States , Waltham

Salary:

160000.00 - 200000.00 USD / Year

Kailera Therapeutics

Expiration Date

Until further notice

Requirements

Bachelor’s degree and 10+ years of relevant biopharmaceutical industry experience or advanced degree with 5+ years of experience
6+ years of experience in clinical supply management
Knowledgeable in the implementation and workings of IRT systems
Ability to create a collaborative environment and manage multiple project activities
Strong computer skills including MS Office
Hands-on, roll-up-your-sleeves, collaborative approach with high sense of urgency and drive for results
Ability to think outside of the box and challenge the status quo
Desire to work in a fast-paced, innovative environment
Ability to travel up to 20%

Job Responsibility

Assist with investigational drug product supply and logistics activities, including, but not limited to, demand forecasting and supply planning, IRT start-up and maintenance, label generation and approval, packaging and labeling operations, release and distribution, expiry extension, returns, reconciliation, destruction, cold chain management, and inventory management
Maintaining oversight in monitoring inventory levels throughout the life of a clinical trial
Support with oversight of packaging and labeling/distribution vendors, including relationship management
Coordinate the preparation of clinical trial pharmacy manuals, packaging methods, batch records, drug labels, shipping documents, destruction certification, and coordinating the origination, proofing, and translation of clinical study labels and generation
Proactively identify potential issues, notify supervisor in a timely manner, and develop mitigating actions
Interpret clinical synopses and protocols to create clinical IMP demand forecasts
Attend clinical study and cross functional meetings as needed
Assist the global supply chain lead in overseeing the execution of multiple clinical trials and proactively identify potential supply chain issues and recommending solutions to global supply chain lead
Lead clinical study close-out activities, including returned goods reconciliation and inventory destruction
Assist with drug supply delivery through coordination of CMC efforts (including, but not limited to, CMC, Supply Chain, Legal, Procurement, Commercial, Regulatory, Clinical Development, and Clinical Operations)

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

Fulltime

Associate Director, Global Supply Chain

The Associate Director, Global Supply Chain reports to the Senior Director, Glob...

Location

United States , Waltham, MA or San Diego, CA

Salary:

160000.00 - 200000.00 USD / Year

Kailera Therapeutics

Expiration Date

Until further notice

Requirements

Bachelor’s degree and 10+ years of relevant biopharmaceutical industry experience or advanced degree with 5+ years of experience
6+ years of experience in clinical supply management
Knowledgeable in the implementation and workings of IRT systems
Ability to create a collaborative environment and manage multiple project activities
Strong computer skills including MS Office
Hands-on, roll-up-your-sleeves, collaborative approach with high sense of urgency and drive for results
Ability to think outside of the box and challenge the status quo
Desire to work in a fast-paced, innovative environment
Ability to travel up to 20%

Job Responsibility

Assist with investigational drug product supply and logistics activities, including, but not limited to, demand forecasting and supply planning, IRT start-up and maintenance, label generation and approval, packaging and labeling operations, release and distribution, expiry extension, returns, reconciliation, destruction, cold chain management, and inventory management
Maintaining oversight in monitoring inventory levels throughout the life of a clinical trial
Support with oversight of packaging and labeling/distribution vendors, including relationship management
Coordinate the preparation of clinical trial pharmacy manuals, packaging methods, batch records, drug labels, shipping documents, destruction certification, and coordinating the origination, proofing, and translation of clinical study labels and generation
Proactively identify potential issues, notify supervisor in a timely manner, and develop mitigating actions
Interpret clinical synopses and protocols to create clinical IMP demand forecasts
Attend clinical study and cross functional meetings as needed
Assist the global supply chain lead in overseeing the execution of multiple clinical trials and proactively identify potential supply chain issues and recommending solutions to global supply chain lead
Lead clinical study close-out activities, including returned goods reconciliation and inventory destruction
Assist with drug supply delivery through coordination of CMC efforts (including, but not limited to, CMC, Supply Chain, Legal, Procurement, Commercial, Regulatory, Clinical Development, and Clinical Operations)

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

Fulltime

Director, CMC and Device Regulatory Affairs

The Director, CMC and Device Regulatory Affairs will lead the implementation of ...

Location

Salary:

220000.00 - 240000.00 USD / Year

Apogee Therapeutics

Expiration Date

Until further notice

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

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

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

New

Contracts & Rights Coordinator

The Contracts & Rights Coordinators support the Media & Entertainment Content te...

Location

United Kingdom , Leeds

Salary:

30000.00 - 37500.00 GBP / Year

ITV

Expiration Date

January 29, 2026

Requirements

Excellent attention to detail is essential
Strong and effective communication, interpersonal and influencing skills and an ability to build successful working relationships at all levels is a must
Ability to effectively manage competing priorities with a customer service approach
delivers quality even when reacting to changing circumstances
able to monitor own work to ensure it reaches successful completion
and plans ahead, anticipating potential problems
Contracts and data management experience is preferred
ideally in a media and/or legal environment
Ability to develop existing processes to meet the changing needs of the business and to continuously improve and develop understanding of new and innovative technologies
Proficient in using Google Suite e.g. Gmail, Sheets & Docs, Microsoft Office e.g. Excel and Word and workflow tools, such as Trello, Jira

Job Responsibility

Support in the end-to-end process from internal sign-off, preparing and issuing initial drafts of agreements and issuing signature copies of contracts and arranging for prompt signature
Ensure the timely and accurate input, update and maintenance of contracts and rights data into ITV’s systems to reflect new information and to apply updates to existing information
To act as a point of contact for all aspects of contracts and rights queries (internal & external), such as copyright clearance, underlying rights queries, industry and regulatory legislation, terms of trade, talent union and music agreements
Provide accurate and timely visibility of rights availability, including clearance and cost information, across the Media & Entertainment division
Build and maintain relationships with all internal stakeholders and external suppliers, managing enquiries with a first class customer service led approach
Support on ad-hoc projects as they arise and co-ordinate such projects across the Legal & Business Affairs team or ITV as required

What we offer

Flexible working with a range of options
Generous holiday allowance, plus you can buy more
Annual bonus opportunity
Competitive pension contribution
Save as you earn - with an opportunity to buy ITV shares
Wellbeing and volunteering days plus a wide range of opportunities to help you live a balanced and healthy life

Fulltime

New

Senior Contracts & Rights Coordinator

To provide a comprehensive and first-class contracts and rights management servi...

Location

United Kingdom , Leeds

Salary:

37500.00 - 42500.00 GBP / Year

ITV

Expiration Date

January 29, 2026

Requirements

Supervisory skills and the ability to coach, develop and train team members is essential
Excellent attention to detail is essential
Strong and effective communication, interpersonal and influencing skills and an ability to build successful working relationships at all levels is a must
Ability to effectively manage competing priorities with a customer service approach
delivers quality even when reacting to changing circumstances
able to monitor own work to ensure it reaches successful completion
and plans ahead, anticipating potential problems.

Job Responsibility

Line manage, support and develop a team of Contracts & Rights Coordinators
set objectives, monitor team performance and serve as a positive role model embodying ITV values and behaviours
Drive processes efficiency, providing and encouraging creative solutions to advance the productivity of the team and ensure that the team is equipped with the resources required to operate as a successful contracts and rights management team
Manage the end-to-end process from internal sign-off, preparing and issuing initial drafts of agreements and issuing signature copies of contracts and arranging for prompt signature
Ensure all contract requests and enquiries are dealt with using a customer service led approach
Ensure the timely and accurate input, update and maintenance of contracts and rights data into ITV’s systems to reflect new information and to apply updates to existing information
To act as a point of contact for all aspects of contracts and rights queries (internal & external), such as copyright clearance, underlying rights queries, industry and regulatory legislation, terms of trade, talent union and music agreements
Build and maintain relationships with all internal stakeholders and external suppliers, managing enquiries with a first class customer service led approach
Support on ad-hoc projects as they arise and co-ordinate such projects across the Legal & Business Affairs team or ITV as required.

What we offer

Flexible working with a range of options
Generous holiday allowance, plus you can buy more
Annual bonus opportunity
Competitive pension contribution
Save as you earn - with an opportunity to buy ITV shares
Wellbeing and volunteering days plus a wide range of opportunities to help you live a balanced and healthy life

Fulltime

Associate Director, CMC Operations

Kailera Therapeutics

Location:
United States , Waltham

Category:
Research and Development

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
January 15, 2026

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