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

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

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

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

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

Indirect Procurement Manager

Lead strategic sourcing and build key relationships in a dynamic, global environ...

Location

Japan , Tokyo

Salary:

9000000.00 - 12700000.00 JPY / Year

Randstad

Expiration Date

April 17, 2026

Requirements

Bachelor's degree in a relevant field (e.g., Supply Chain Management, Business Administration)
Minimum 10 years of experience in indirect procurement, with a proven track record of success
Strong negotiation and contract management skills
Experience working with global teams and stakeholders
Excellent communication and interpersonal skills, with fluency in English and Japanese
Proficient in relevant procurement software and systems
Analytical skills with the ability to develop and implement strategic plans
Experience managing a significant financial spend budget
Understanding of Japanese business culture and regulatory environment
Strong problem-solving and decision-making abilities

Job Responsibility

Lead the development and execution of indirect procurement strategies for Japan, aligned with global objectives
Manage the full procurement lifecycle, from sourcing to contract negotiation and supplier management
Develop and maintain strong relationships with key internal stakeholders and external suppliers
Drive cost savings and efficiency improvements across the procurement process
Ensure compliance with all relevant procurement policies and regulations
Collaborate with regional and global procurement teams to share best practices and leverage synergies
Analyze market trends and identify opportunities for innovation and improvement
Prepare and manage budgets, ensuring effective financial control

What we offer

健康保険
厚生年金保険
雇用保険
土曜日
日曜日
祝日

Fulltime

New

National Project Officer

The National Project Officer will be responsible for preparation and implementat...

Location

Viet Nam , Hanoi

Salary:

Not provided

UNESCO

Expiration Date

February 26, 2026

Requirements

Advanced university degree (Master’s or equivalent) in relevant fields such as water resources management, water sciences, natural sciences, environmental sciences, Climate Change, disaster risk management etc.
At least four (4) years of relevant progressively professional experiences in working on natural resources management, climate change, water resources, development or any relevant fields
Familiarity with international DRR and climate frameworks (e.g. Sendai Framework, climate adaptation approaches) and their application at national or local level
Demonstrated experience in project coordination or management, including planning, implementation, monitoring, and reporting
Sound knowledge of the major development issues with regards to DRR, water resources and climate change in Viet Nam
Proven experiences in coordination and/or managing development projects, particularly at national level
Vietnamese National only

Job Responsibility

Coordinate and oversee the preparation/inception phase of the projects in Vietnam
Responsible for developing the workplans, implementation and day-to-day coordination/management
Undertake technical tasks, organize activities, mobilize experts
Coordinate and supervise activities in closely working with counterparts
Ensure project visibility, communication, and dissemination of results
Maintain effective liaison and partnerships with government counterparts, participating agencies, and other partners
Provide support for the monitoring, and regular reporting on the progress of the project
Coordinate and lead the M&E data compilation
Regularly oversee the financial and administrative aspects of the projects
Report on the progress of activities/projects on a regular basis

Fulltime

New

Senior Consultant - Women in Learning Leadership Project

The consultant will support the WiLL (Women in Learning Leadership) research age...

Location

France , Paris

Salary:

Not provided

UNESCO

Expiration Date

February 16, 2026

Requirements

Advanced university degree (Master or PhD) in education, economics, social sciences, gender or related fields
At least ten years of professional experience in quantitative research and report writing in education and gender
At least two years of professional experience at the international level
Demonstrated expertise in quantitative data analysis, including the use of statistical software and education datasets
Demonstrated experience in research design and implementation, including development of analytical frameworks, tools and protocols
Strong analytical and writing skills, with a proven track record of analytical outputs (e.g. research reports, policy briefs, technical notes, publications)
Proven experience working with Ministries of Education, international organizations, or development partners
Experience in sub-Saharan Africa, including collaboration with national counterparts and local stakeholders
Excellent written and oral proficiency in French and English
Ability to travel internationally, including in fragile and challenging context countries

Job Responsibility

Provide technical guidance to reach the project objectives
Lead or contribute to global research including identification, creation and analysis of assessment tools, analysis of education datasets and drafting policy briefs
Lead or contribute to country-level work including analysis of primary data, report writing, and providing technical guidance for data collection
Lead or participate in data collection activities including managing ethical protocols, establishing sampling strategy, drafting questionnaires, recruiting survey firms, training enumerators, and supervising data collection and cleaning
Contribute to project management including coordination with national and international partners, reporting, participating in policy dialogue and fund-raising efforts
Contribute to publication and dissemination of research results
Ensure quality assurance of institutional analysis

What we offer

Travel expenses will be covered by IIEP according to UN travel rules (airplane tickets + DSA)

Fulltime

!

New

Bilingual Lease Services Administrator

We are seeking a highly organized and detail-oriented Bilingual Lease Services A...

Location

Canada , Burlington

Salary:

31.00 CAD / Hour

Randstad

Expiration Date

April 09, 2026

Requirements

Post-secondary degree or diploma in Business Administration, Office Management, or a related field
2+ years of experience in a professional office administration or document coordination role
High proficiency in MS Office (Excel, Outlook, Word) and comfortable learning new database systems
Strong attention to detail with a focus on administrative accuracy and file organization
Professional verbal and written communication skills for coordinating with internal teams
Ability to manage a high volume of paperwork and meet daily administrative deadlines
Bilingual (French/English) is a requirement

Job Responsibility

Perform daily data entry and administrative processing for new lease and loan contracts
Organize and review physical and digital document packages to ensure all required signatures and attachments are present
Coordinate the distribution of documents between the sales, credit, and accounting departments
Update and maintain accurate customer records and contract status within the internal database
Manage the administrative workflow for account payoffs, terminations, and routine file updates
Monitor shared email inboxes and respond to general administrative inquiries regarding contract status
Ensure all filing and record-keeping meets corporate administrative standards and provincial privacy guidelines

What we offer

Strong opportunity to be considered for a permanent position within the organization
Experience working with a globally recognized leader in the financial sector
Collaborative and professional work environment with structured training
Opportunity to develop specialized administrative skills within the finance industry

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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