Senior Director, Analytical Development, CMC Small Molecule
Location
United States
Posted
82 days ago
Salary
$250K - $300K / year
Seniority
Lead
No structured requirement data.
Job Description
Senior Director, Analytical Development, CMC Small Molecule
Centessa Pharmaceuticals, LLC
Centessa Pharmaceuticals plc (Nasdaq: CNTA) new kind of pharmaceutical company with a deconstructed R&D environment that prioritizes data driven decision making led by subject matter experts. Centessa is advancing a portfolio of high conviction programs with strong biological validation. Our asset-centric model offers a unique R&D logic that has been applied by single asset companies to improve productivity. This operating model has minimal centralized infrastructure, reduced hierarchy, and exclusive focus on data driven capital allocation. Our teams are uniquely incentivized to expeditiously interrogate key scientific hypotheses. We believe the asset-centric model can lead to improved success rates for programs with greater speed and modest costs. Description of Role Centessa’s CMC group is seeking a Senior Director of Analytical Development within the CMC group. The successful candidate will have hands-on experience in the development and validation of raw material, in-process, small molecule drug substance, and solid oral dose drug product methods at all stages of development. T he Senior Director will drive analytical method gap assessments, method development, and strategy at various CDMOs and liaise cross-functionally with drug substance and drug product teams across programs. Comprehensive working knowledge of cGMP and Regulatory guidance as they relate to regulatory starting material, drug substance and drug product development, characterization, release, and stability testing of small molecules is paramount. This position will be accountable for all analytical CMC data from external CDMOs to meet company deliverables and timelines. Travel to vendors both domestically and internationally will be required. Key Responsibilities - Lead analytical strategy related to phase-appropriate method development, validation, and product characterization for multiple programs - Collaboratively work in a team environment to lead drug substance and drug product analytical development activities primarily at third-party vendors including method implementation, qualification/validation, and transfer in support of pre-IND through Registrational programs - Review method validation protocol and reports, and test data for release, stability, and characterization - Save and store documentation, generate stability result tables, file stability data for expiry and shelf-life assignments - Lead specification settings based upon batch history and supporting analytical data - Act as the CMC team analytical representative member in program development teams - Act as role model and subject matter expert for junior analytical scientists - Significantly contribute to CMC analytical aspects of regulatory filings including regulatory starting material justifications, justification of specifications, discriminatory and quality control dissolution method development, and structural elucidations - Review and drafting of internal technical reports and information for analytical sections in global submission documents and modules (e.g. IND, IMPD, NDA, MAA, etc) as well as responses to Regulatory requests for information - Work cross-functionally with Quality as a technical expert to aid in analytical OOE/OOT/OOS investigations, deviations, and other troubleshooting - Active participation in batch record review Qualifications - Advanced degree in chemistry, pharmaceutical sciences, or related field (minimum BS/MS required; PhD strongly preferred) with 15+ years of small molecule pharmaceutical industry experience - Extensive experience in late phase analytical development of small molecule oral solid dosage forms - Deep expertise in cGMP and ex-US regulatory requirements for pharmaceutical products - Strong technical background in chemical and physical characterization, including polymorphism, particle size, residual solvents, process impurities (e.g., genotoxic, nitrosamines), and forced degradation mechanisms - Significant experience in analytical method development and GMP qualification/validation, including assay, related substances, and dissolution - Proven ability to manage and direct outsourced analytical activities, including assay development, stability, and quality control at CDMOs - Hands-on experience designing, managing, and interpreting stability programs (real-time, accelerated, and forced degradation) - Strong understanding of product quality attributes and control strategies for small molecule synthetic processes - Demonstrated leadership in coordinating analytical and broader CMC activities supporting development and commercialization - Excellent project management, organizational, and prioritization skills in fast-paced, multi-project environments - Strong analytical planning, resource management, and budget oversight skills across global CDMO networks - Effective decision-maker and communicator, able to work independently while collaborating across functions and organizational levels Compensation The annual base salary range for this position is $250,000.00 to $300,000.00. Individual compensation within this range will be determined based on a variety of factors, including qualifications, skills, relevant experience, and job knowledge. In addition to base pay, this role is eligible for a discretionary annual bonus and participation in our equity program, allowing you to share in Centessa’s long-term success. Centessa also offers a comprehensive benefits package, which includes a 401(k) plan, company-sponsored medical, dental, vision, and life insurance, generous paid time off, and a health and wellness program. Work Location The Senior Director, Analytical Development, CMC (Small Molecule) role is a remote role based in the US, with travel. POSITION: Full-Time, Exempt EEOC Statement: Centessa Pharmaceuticals believes in a diverse environment and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion, or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Centessa Pharmaceuticals will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Please note: We will not assign referral rights for any unsolicited resumes from recruitment agencies.
Related Guides
Related Categories
Related Job Pages
More SDET Jobs
ABOUT OUR CLIENT For over 75 years, our client has given hope to borrowers who have been turned away by the major lenders. By providing a flexible approach to the assessment of their clients' finances, they have supported countless families with opportunities to secure their future. Their team of professionals share a wealth of experience across all areas of banking and finance, having financed more than 30,000 dwellings to date. THE OPPORTUNITY Reporting to the Executive GM of Distribution and Mortgage Operations, this role focuses on consistently and effectively promoting the businesses commitment to ethical, reliable, and helpful service that has earnt our client a strong reputation in the market. With a focus on finding new opportunities, researching, qualifying leads, closing opportunities and completing outbound sales activities. You will strengthen relationships with brokers and aggregators and ensure that the brand continues to grow and succeed. In addition, you will strive to reach monthly settlements targets that will contribute to the continued growth and success of the business. Key responsibilities: Lead Generation & Broker Management - Identify and develop sales opportunities through research, lead generation and outbound sales activities. - Build and maintain relationships with brokers (warm leads) for long-term success. - Manage a portfolio of brokers across designated locations. - Build the brand in NSW and advocate for the business at professional development days, webinars and in daily communications with external stakeholders. - Assist with onboarding and supporting new brokers. - Ensure high-level customer service for both internal and external stakeholders Sales & Pipeline Management - Achieve sales targets through growth strategies and exceptional service. - Manage outbound calls, virtual & face to face meetings, and the sales pipeline effectively. - Utilise CRM effectively (Dynamics) for data entry and activity management. - Collaborate with the sales team to convert leads and opportunities. Professional Development & Growth - Attend industry events and development days for networking and brand awareness. - Conduct research on competitors, market trends, and lead acquisition methods. Teamwork & Support - Partner with Credit & Broker Support teams and colleagues for knowledge sharing and maximising sales. - Assist in training and development of other team members. - Participate actively in team conversations and meetings. WHAT YOU NEED TO SUCCEED To be successful in this unique role, you will possess the following qualities: - Unwavering motivation and desire to achieve sales targets and other KPI’s. - High level of attention to detail. - Advanced problem-solving skills. - Capable of utilising different communication and negotiation skill sets. - Comprehensive understanding of consumer and business lending principles and practices. - Speed to market. - Able to work effectively in a team environment. - Possess relationship building skills with internal and external counterparts. YOUR EXPERIENCE - Must have a current and valid driver’s license to enable you to complete face-to-face visits with brokers. - University Degree or Diploma in Finance, Business or Accounting (or other related field of study). - 7+ year’s experience in Business Development, Account Management or Sales (or other related role). Ideally experience in banks or non-banking lending businesses would be preferred. - Experience within a goal and target oriented position within sales. - Exposure to CRM systems such as Microsoft Dynamics systems would be highly advantageous. HOW TO APPLY You may apply using your LinkedIn profile, however, we would love to know more. Therefore, we welcome the inclusion of a CV and/or attached a cover letter. For further information, please contact Georgia Roberts via groberts@partale.com.au
Web Development Specialist
Geeks on SiteGeeks on Site is dedicated to providing quality computer repair & support services for homes & businesses nationwide.
Web Development Specialist (Remote – LATAM Preferred) About Otte Polo Group: Otte Polo Group is a fast-growing U.S.-based organization supporting multiple brands across industries, including tech support, customer service, and fulfillment. Job Summary: The Web Development Specialist will be responsible for managing and improving all websites and web applications within the Otte Polo Group ecosystem. This includes brands like GeeksOnSite, Responsive Answering, and Phase V Fulfillment. You’ll work with a team of developers, ensure site performance, oversee new feature rollouts, and work closely with marketing and operations to drive business goals through digital innovation. Key Responsibilities: - Lead front-end and back-end development across all company websites and platforms. - Ensure high-performing, responsive, SEO-optimized websites. - Manage development timelines, updates, bug fixes, and feature releases. - Collaborate with the marketing team to implement landing pages, CRO testing, and content updates. - Ensure website security, backups, and codebase management. - Recommend and implement improvements to site architecture and tools.
Web Development Specialist
Geeks on SiteGeeks on Site is dedicated to providing quality computer repair & support services for homes & businesses nationwide.
Web Development Specialist (Remote – LATAM Preferred) About Otte Polo Group: Otte Polo Group is a fast-growing U.S.-based organization supporting multiple brands across industries, including tech support, customer service, and fulfillment. Job Summary: The Web Development Specialist will be responsible for managing and improving all websites and web applications within the Otte Polo Group ecosystem. This includes brands like GeeksOnSite, Responsive Answering, and Phase V Fulfillment. You’ll work with a team of developers, ensure site performance, oversee new feature rollouts, and work closely with marketing and operations to drive business goals through digital innovation. Key Responsibilities: - Lead front-end and back-end development across all company websites and platforms. - Ensure high-performing, responsive, SEO-optimized websites. - Manage development timelines, updates, bug fixes, and feature releases. - Collaborate with the marketing team to implement landing pages, CRO testing, and content updates. - Ensure website security, backups, and codebase management. - Recommend and implement improvements to site architecture and tools.
Web Development Specialist
Geeks on SiteGeeks on Site is dedicated to providing quality computer repair & support services for homes & businesses nationwide.
Web Development Specialist (Remote – LATAM Preferred) About Otte Polo Group: Otte Polo Group is a fast-growing U.S.-based organization supporting multiple brands across industries, including tech support, customer service, and fulfillment. Job Summary: The Web Development Specialist will be responsible for managing and improving all websites and web applications within the Otte Polo Group ecosystem. This includes brands like GeeksOnSite, Responsive Answering, and Phase V Fulfillment. You’ll work with a team of developers, ensure site performance, oversee new feature rollouts, and work closely with marketing and operations to drive business goals through digital innovation. Key Responsibilities: - Lead front-end and back-end development across all company websites and platforms. - Ensure high-performing, responsive, SEO-optimized websites. - Manage development timelines, updates, bug fixes, and feature releases. - Collaborate with the marketing team to implement landing pages, CRO testing, and content updates. - Ensure website security, backups, and codebase management. - Recommend and implement improvements to site architecture and tools.
