Associate Director of Product Development Job at YipitData

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

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 / Director, Medical Writing

Beam is seeking a highly talented and motivated AD/Director to join our growing ...

Location

United States , Cambridge

Salary:

180000.00 - 260000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

Bachelor’s degree required
MS, PharmD, or PhD preferred in a life science or health discipline
12+ years of clinical/regulatory medical writing experience in the pharmaceutical or biotech industry
A solid understanding of ICH guidelines, GxP, and relevant regulatory requirements
Demonstrated understanding of clinical regulatory documents (ie, protocol, IB, CSR, summaries for product filing, etc.) and experience as a lead author with such documents
Excellent communication skills, both oral and written
Ability to build strong relationships and work collaboratively across functions
Effective organizational and meeting skills and attention to detail
Experience with workflow management within standard document management systems
Ability to come onsite when needed such as for important meetings and team/company functions

Job Responsibility

Act as lead writer for clinical regulatory documents for the hematology program
Plan and lead the development of clinical study documents, working with cross-functional colleagues
Work closely with the regulatory team and other writers on regulatory document submissions
Assist with developing and maintaining medical writing process documents
Assist with evaluation and interpretation of the medical literature across several domains, such as study design, clinical development planning, statistical meaningfulness, and scientific rigor
Contribute to statistical output plans concerning organization and table layout for specific documents
Project management, strategic design, planning, team input, and reviews
Opportunities for management/mentorship of other writers

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

Associate Director Training

Location

Egypt

Salary:

Not provided

Concentrix

Expiration Date

Until further notice

Requirements

7+ years of experience in Learning & Development or Operations
At least 3-4 years in a senior management role (managing other managers)
Proven track record in a BPO, Contact Center, or fast-paced SaaS environment with a focus on product/technical training
Extensive experience managing external client relationships, specifically regarding performance deliverables and onboarding strategies
Ability to interpret complex data sets (attrition, throughput, CSAT, speed to proficiency) to drive business decisions
Experience leading large-scale projects, such as site launches or global curriculum rollouts, using agile or waterfall methodologies
Deep understanding of Learning Management Systems (LMS) and modern instructional design methodologies (ADDIE, SAM, etc.)
Ability to move beyond daily firefighting to plan 6-12 months ahead
Strong communication skills with the ability to influence senior leadership and external stakeholders
Capable of navigating a high-pressure, constantly changing environment while maintaining team stability

Job Responsibility

Drive Training Strategy: Define and execute the long-term training vision, ensuring full alignment with product roadmaps, organizational goals, and client service level agreements (SLAs)
Oversee high-level resource planning and capacity management to ensure scalability for new client launches, product transitions, and seasonal ramps
Manage the training budget, analyze cost-per-hire/training, and utilize data analytics to measure Training ROI, ensuring maximum efficiency in delivery
Act as the primary escalation point for key enterprise clients regarding training performance
lead high-stakes business reviews (QBRs) and strategy sessions
Partner with Product, Operations, and Talent Acquisition to facilitate seamless product transitions and ensure the training function is integrated into the broader business lifecycle
Manage high-level conflicts or gaps between client expectations and internal delivery, negotiating solutions that protect the organization’s interests while maintaining client satisfaction
Direct the design framework for internal and external training programs
ensure content is scalable, compliant, and adapted for diverse learner needs (including virtual and self-paced models)
Utilize post-training evaluation data and performance metrics to identify curriculum gaps and drive systemic improvements in training efficacy

Associate Strategy Director

Strategy Director Strategists at AKQA make our client’s business their business....

Location

United Kingdom , London

Salary:

Not provided

AKQA

Expiration Date

Until further notice

Requirements

Experience in a relevant strategy role within a creative agency or consultancy environment
Generalist strategist with significant experience in products, platforms, and data, complemented by strong experience or a keen interest in brand, marketing, and communications strategy
Insatiable curiosity and can observe and identify patterns, trends, and insights, turning research and data into effectiveness and performance
Lateral and creative thinker with the ability to make complex topics simple, and a passion for creativity, innovation, and compelling experiences
A robust understanding of user journeys, product ecosystems, and how to drive innovative solutions throughout the product lifecycle
Strong understanding of how business, brands, and consumers interact, and how technology is impacting their lives
Familiarity with the design, application, and analysis of a wide range of quantitative and qualitative research
Passionate about collaboration, open-minded, and experienced in working with people from diverse cultures
Understand the big picture and have a sharp attention to detail, while always striving for best-in-class work

Job Responsibility

Understand the client’s audiences, objectives, and priorities, and lead the definition of solutions to meet these needs
Execute research to distil and design insight that drives forward creative solutions to client brief objectives
Provide strategic direction for product design, digital platform development, and user experience, as well as brand, marketing, and communications initiatives, identifying key value propositions, user needs, and business value
Develop strategies that define the vision and roadmap for digital products and platforms, ensuring market differentiation and clear user value
Develop comprehensive strategies that detail tactics across the entire customer experience, encompassing brand communications, product lifecycle, and user journeys, translating strategic recommendations into actionable campaigns, product features, services, and experiences
Craft compelling narratives in presentations and to sell your work to clients, ensuring alignment of client objectives to strategic imperatives
Co-create closely with creative, experience, and technology teams to develop effective and performant solutions
Identify key opportunities to drive client value, satisfaction, and growth
Plan and lead client workshops and research sessions
Write briefs that provide clarity for creativity and collaborate to refine, align, and shape them into effective solutions

What we offer

We provide an extensive range of benefits

Associate Strategy Director

Strategy Director Strategists at AKQA make our client’s business their business....

Location

United Kingdom , London

Salary:

Not provided

AKQA

Expiration Date

Until further notice

Requirements

Experience in a relevant strategy role within a creative agency or consultancy environment
Generalist strategist with significant experience in products, platforms, and data, complemented by strong experience or a keen interest in brand, marketing, and communications strategy
Insatiable curiosity and can observe and identify patterns, trends, and insights, turning research and data into effectiveness and performance
Lateral and creative thinker with the ability to make complex topics simple, and a passion for creativity, innovation, and compelling experiences
A robust understanding of user journeys, product ecosystems, and how to drive innovative solutions throughout the product lifecycle
Strong understanding of how business, brands, and consumers interact, and how technology is impacting their lives
Familiarity with the design, application, and analysis of a wide range of quantitative and qualitative research
Passionate about collaboration, open-minded, and experienced in working with people from diverse cultures
Understand the big picture and have a sharp attention to detail, while always striving for best-in-class work

Job Responsibility

Understand the client’s audiences, objectives, and priorities, and lead the definition of solutions to meet these needs
Execute research to distil and design insight that drives forward creative solutions to client brief objectives
Provide strategic direction for product design, digital platform development, and user experience, as well as brand, marketing, and communications initiatives, identifying key value propositions, user needs, and business value
Develop strategies that define the vision and roadmap for digital products and platforms, ensuring market differentiation and clear user value
Develop comprehensive strategies that detail tactics across the entire customer experience, encompassing brand communications, product lifecycle, and user journeys, translating strategic recommendations into actionable campaigns, product features, services, and experiences
Craft compelling narratives in presentations and to sell your work to clients, ensuring alignment of client objectives to strategic imperatives
Co-create closely with creative, experience, and technology teams to develop effective and performant solutions
Identify key opportunities to drive client value, satisfaction, and growth
Plan and lead client workshops and research sessions
Write briefs that provide clarity for creativity and collaborate to refine, align, and shape them into effective solutions

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 of Product Development

YipitData

Location:
United States

Category:
IT - Software Development

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
January 02, 2026

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