Associate Director, Analytical Development and Quality Control Job at Kailera Therapeutics (Waltham)

Associate Director, Analytical Development and Quality Control

The Associate Director, Analytical Development and Quality Control will support ...

Location

United States , San Diego

Salary:

160000.00 - 200000.00 USD / Year

Kailera Therapeutics

Expiration Date

Until further notice

Requirements

10+ years of experience, or 5+ with advanced degree, in the pharmaceutical/biotech industry with experience in all phases of innovative drug development and commercial launch in accordance with global CMC regulatory filings (IND/NDA/MAA, etc.)
Strong expertise in analytical techniques HPLC/UPLC, LC–MS, SE-HPLC, dissolution, along with extractables and leachable analysis
Knowledge of drug development activities with respect to cGMP, quality systems, ICH guidelines, global regulatory requirements, and USP, EP, JP, and CHP requirements
Hands-on experience supporting early- and late-stage CMC development, stability programs, and specification setting
Proven experience leading OOS/OOT investigations, deviations, CAPAs, and change controls
Strong track record of working with CROs/CMOs and managing external analytical/testing activities
Excellent technical writing skills for analytical reports and regulatory submissions (IND/IMPD, NDA/BLA)
Demonstrated leadership ability with experience mentoring and developing scientific staff
Strong communication, cross-functional collaboration, and project-management skills
Innovative team-player with high energy for our dynamic company environment

Job Responsibility

Support analytical development and QC activities related to characterization of drug substances and drug products from early-stage clinical development through commercialization
Maintain current knowledge in analytical methods and control strategies supporting a variety of molecule platforms and dosage forms
Oversee and provide scientific leadership on QC testing for DS/DP at vendors, ensuring cGMP compliance, data integrity, and timely delivery of analytical results
Direct investigations including OOS/OOT, deviations, and CAPAs, and provide strong analytical rationale
Design and manage stability programs (accelerated, long-term, bracketing/matrixing) supporting early and late clinical phases
Interpret stability trends and establish shelf-life/retest periods consistent with ICH guidelines and peptide behavior
Support comparability assessments for process changes, analytical method updates, or site transfers
Communicate CMC project status to key stakeholders cross-functionally and assist in driving decision-making
Participate in cross-functional CMC teams for the project(s) assigned to ensure adequate development and execution of CMC plan/strategies as needed
Author and review CMC sections of IND/IMPD and NDA submissions and address regulatory questions

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

New

Associate Director, Quality Control – Analytical Sciences

We are seeking an Associate Director to join the QC Analytical Sciences team in ...

Location

United States

Salary:

165000.00 - 185000.00 USD / Year

Apogee Therapeutics

Expiration Date

Until further notice

Requirements

Advanced degree in a relevant discipline (e.g., analytical chemistry, biochemistry, microbiology or related field)
7+ years of analytical development & quality control experience with complex biologics spanning early and late-stage development (GMP experience required)
Expertise/competence in several relevant analytical techniques such as HPLC, spectrophotometry, mass spec, ELISA, bioassay and microbiology
Strong understanding of global regulatory requirements (e.g., FDA, EMA, ICH) as they relate to analytical development, QC testing, and method validation
Hands-on experience supporting regulatory submissions (INDs, IMPDs, BLAs/NDAs, or equivalents), including preparation, review, and response to analytical sections
Excellent communication skills with an ability to collaborate effectively across functional lines
Ability to work independently and multi-task in a fast-moving organization
Availability to participate in calls across multiple international time zones
Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless
Position requires up to 30% travel including mandatory in-person attendance at Apogee All Hands meetings typically held twice per year

Job Responsibility

Support the harmonization of QC analytical methods across internal laboratories, external vendors, and contract testing organizations
Partner with global and cross-functional teams to ensure successful implementation of harmonized methods
Support method transfers, validations, and comparability studies, ensuring adherence to regulatory and quality requirements
Provide technical oversight to vendors and contract laboratories, including troubleshooting and resolution of method-related issues
Author and review regulatory submissions (e.g., INDs, BLAs, MAAs) and support technical documentation, ensuring clarity, accuracy, and compliance with global guidelines
Generate and review technical documents, including protocols, reports, and method lifecycle documents

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

Senior Vice President - Underwriter - (Structured Credit and Real Estate Underwriting)

The Senior Vice President position will hold a critical role within the Structur...

Location

India , Mumbai

Salary:

Not provided

Citi

Expiration Date

Until further notice

Requirements

13+ years of credit, portfolio management or product experience (preferably real estate underwriting or asset management) in a financial institution, rating agency, financial guarantor, or asset management firm
Experience in leading a team and in coaching and mentoring junior bankers
Excellent organizational skills, prioritizing capabilities, attention to detail, and the ability to complete assignments within required deadlines in a fast-paced environment
Ability to understand capital markets products and complex financing and product structures
Ability to provide strategic insights and strong sensitivity to macro and regulatory issues, and impact of such issues on the various Risk families, including operational and franchise risks
Pro-active disposition with ability to work autonomously and within a team
Typically deals with complex and variable issues with substantial potential impact, where development of an approach/taking of an action involves weighing various alternatives and balancing potentially conflicting needs
Requires good analytical skills in order to filter, prioritize and validate potentially complex material from multiple sources
Knowledge of wholesale loan (syndicated / bilateral) product and business, including an understanding of legal loan documentation, loan / funding mechanics, deal structure, funds flows, etc.
On track for internal Senior Credit Officer designation is a plus

Job Responsibility

Accountability for ensuring strong analysis of the assigned Real estate portfolio ensuring consistencies with industry leading practices and compliance with all internal risk policies, standards and procedures
Interface with and support bankers in underwriting requests for commercial credit extensions for new and existing clients with ownership responsibilities for sound credit decisions and compliance with internal procedures/credit risk policy guidelines and standards
Adoption of leading practices in credit analysis, underwriting, and monitoring, including the end-to-end underwriting process, from early origination discussions to development of credit approval memos, and senior approval forums
Supervise analysts and associates to perform periodic monitoring of the portfolio
Ensure maintenance of organized credit files for credit, regulatory, and compliance purposes and ensuring compliance with WCR policies and processes
Perform quality control of the approval memos to ensure accuracy and completeness of input
Ensures team monitors the ongoing compliance of assigned deals with the documented financing terms and conditions, portfolio performance and financial triggers and makes appropriate recommendations with the aim of identifying and mitigating credit risks
Ensure ongoing and timely feedback and coaching of junior team to sustain a strong credit culture and an unwavering commitment to excellence in analysis and execution
Provide support to Director and other senior team members, lead projects and initiatives in the wider team
Support the ICM Real Estate Underwriting Verticals (Citi Community Capital, CRE) on strategic initiatives/projects

What we offer

Global Benefits
Best-in-class benefits
Work-life balance

Fulltime

Associate Director, GMP Quality Assurance

We are seeking a dynamic and results-driven Associate Director of GMP Quality As...

Location

United States

Salary:

160000.00 - 185000.00 USD / Year

Apogee Therapeutics

Expiration Date

Until further notice

Requirements

A bachelor’s degree in relevant scientific discipline or equivalent is required
A minimum of 7 years of experience in GMP quality assurance within the biotech or pharmaceutical industry, with direct experience in the manufacture of monoclonal antibodies or biologics
Knowledge of medical device Quality System Regulations with direct experience in 21 CFR Part 4, Part 820, ISO 13485 and ISO 14971
In-depth knowledge of GMP regulations and guidelines, including FDA, EMA, and ICH requirements
Experience with analytical instrumentation, methods, validation, and investigations including stability program management
Experience using electronic QMS to monitor, report, and track quality tasks, and key quality performance indicators
Demonstrated strong oral and written communication skills, along with effective interpersonal abilities to influence, drive change, and foster a collaborative, team-oriented culture
Proven excellence in problem-solving and critical thinking, with flexibility and creativity to address the challenges of a dynamic, growing organization
Skilled in managing multiple projects simultaneously, effectively prioritizing and adapting to aggressive timelines and shifting priorities
Position requires up to 20% travel including mandatory in-person attendance at Apogee All Hands meetings typically held twice per year

Job Responsibility

Lead and support QA activities for downstream manufacturing, including Drug Product, Finished Drug Product, and devices such as pre-filled syringes and auto-injectors
Maintain and enhance robust GMP quality systems encompassing documentation, change control, deviations, CAPA, quality events, and continuous improvement initiatives
Stay current with regulatory changes, industry trends, and implement new requirements into company policies and procedures
Utilize risk-based approaches to quality management, proactively identifying and mitigating quality risks across the organization
Develop, monitor, and report key quality metrics to drive GMP compliance and improve product quality
Ensure all personnel are adequately trained in GMP requirements and quality procedures
Keep comprehensive and accurate records and reports of all quality assurance activities
Foster a culture focused on quality, compliance, data integrity, patient safety, collaboration, and teamwork
Prepare and support the organization for regulatory authority inspections and maintain inspection readiness
Collaborate with cross-functional teams to solve problems and drive innovation in quality systems and processes

What we offer

A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless
Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly
Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
We provide competitive time off, including 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

Director, International Sourcing

The Director, Sourcing is responsible for leading a sourcing team consisting of ...

Location

Hong Kong; Singapore , Kwun Tong; Singapore

Salary:

Not provided

Disney

Expiration Date

Until further notice

Requirements

10 - 15 years experience in Global Sourcing, Product Development, or equivalent
Bachelor’s Degree
Product-specific technical degree and/or manufacturing experience a plus

Job Responsibility

Develops, mentors, and trains teams, providing appropriate direction, resources, and environment needed for success
Manages global initiatives, projects, processes & resources to produce desired outcomes
Engages suppliers & colleagues across the organization to optimize performance, ensure Disney Quality Requirements, and drive innovation within supply base
Educates & cultivates suppliers to ensure production & development of project meets desired timeline
Oversees the development of short and long-term sourcing strategies for managed division
Travels domestically and internationally to evaluate the viability of worldwide market opportunities, build vendor relationships, and continuously expand product knowledge/expertise
Drives market exploration and diversification
Uses product knowledge to drive leveraging opportunities across the segment and/or other Disney lines of businesses
Fine tune measures to achieve cost mitigation goals
Proposes and implements solutions to achieve sourcing strategies for global and local developed items

In-Business QA, Business Risk Credit Analyst

The role involves quality assurance relating to Wholesale Credit Risk processes,...

Location

India , Mumbai

Salary:

Not provided

Citi

Expiration Date

Until further notice

Requirements

Relevant work experience in Risk & Control function focusing on Wholesale Credit Risk
Hands on experience of Data Science / Data Analytics
Deep understanding of control framework in the banks
Experience in BCBS 239 is highly desirable
Python is essential
Tableau and SQL are added advantages
Consistently demonstrates clear and concise written and verbal communication skills
Effective organizational influencing skills required
Excellent problem-solving skills
Ability to see the big picture with high attention to critical details

Job Responsibility

Support the In-Business Quality Assurance Head of Data Analytics to set the global strategy for and lead the implementation and ongoing delivery of a robust Data analytics and testing program for the Quality Assurance function as it relates to Wholesale Credit Risk (WCR) data governance
Provide effective challenge on the design and operation of the data and credit processes within ICM and report any identified gaps and concerns through quarterly reports published to ICM senior management
Ability to query and clean complex datasets from multiple sources to funnel into advanced statistical analysis
Hands-on experience in designing, planning, prototyping, productionizing, deploying, maintaining, and documenting reliable and scalable data science solution
Perform design and operational effectiveness assessments of various business processes within Wholesale Credit Risk
Participate and independently lead Quality Assurance Reviews (QAR) covering data-relevant aspects
Read policies, standards, and procedures to understand key pillars, responsibilities, associated risks, and expected controls for the business process(es) in scope
Lead data discovery to identify data lineage and controls for the defined business process in scope
Evaluate findings identified through the Quality Assurance process, determine materiality, and partner with business teams to drive sustainable remediation
Collaborate within IBQA teams and with QA Directors and provide them with analytics insights

Fulltime

Director, Technical Program Management

The Director of Technical Program Management will lead strategic portfolio manag...

Location

United States , Bethesda

Salary:

Not provided

Aledade, Inc.

Expiration Date

Until further notice

Requirements

10+ years of program management, project management or product management experience and a track record of building solutions that create value
4 years of management experience
Deep understanding of product development lifecycles, software development methodologies (Agile, Scrum, Kanban) and understanding of engineering processes.
Proven ability to work effectively with cross-functional teams, including roles such as product managers, business analysts, engineers and designers
Ability to translate technical concepts to non-technical stakeholders and vice versa.
Proficiency in project management and collaboration tools commonly used in software development, such as Jira, Confluence, or GitHub.
Understanding of the specific risks associated with software development projects and the ability to develop and execute risk mitigation plans.

Job Responsibility

Program delivery leadership: Drive planning and execution across multiple teams and platforms, aligning initiatives to business outcomes and OKRs. Orchestrate dependencies, resources, and timelines to deliver reliably at scale. Serve as the accountable owner for portfolio health, including on-time delivery, scope integrity, and benefit realization.
Cross-functional leadership alignment: Create alignment among Product, Engineering, Analytics, Security and GTM on goals, scope, and success criteria. Provide clear, concise communications and executive-ready reporting on status, risks, and trade-offs to enable timely decisions.
Build and lead the technical program management organization
program governance and delivery excellence: Hire, develop, and coach TPMs, fostering a culture of ownership, collaboration, and continuous improvement. Establish program governance, operating rhythms, and tooling (e.g., roadmapping, Jira, dashboards) that improve predictability and transparency. Define and track core delivery metrics (e.g., on-time rate, lead time, dependency aging) and implement data-driven improvements.
Risk, compliance, and quality management: Proactively identify and manage program risks, escalations, and change control to protect timelines and outcomes. Ensure delivery practices align with healthcare requirements such as data privacy and security (e.g., HIPAA), interoperability (e.g., HL7/FHIR), and, where applicable, certifications or regulatory considerations. Partner with Security, Compliance, and QA to prepare for audits, maintain release discipline, and uphold patient safety and product reliability.

What we offer

Flexible work schedules and the ability to work remotely are available for many roles
Health, dental and vision insurance paid up to 80% for employees, dependents and domestic partners
Robust time-off plan (21 days of PTO in your first year)
Two paid volunteer days and 11 paid holidays
12 weeks paid parental leave for all new parents
Six weeks paid sabbatical after six years of service
Educational Assistant Program and Clinical Employee Reimbursement Program
401(k) with up to 4% match
Stock options

Fulltime

Associate Director, Analytical Development and Quality Control

Kailera Therapeutics

Location:
United States , Waltham

Category:
Research and Development

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
January 15, 2026

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