Associate Director, CMC Analytical Chemistry

Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which cardiac muscle performance is compromised. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact myocardial muscle function and contractility.

At Cytokinetics, each team member plays an integral part in advancing our mission to improve the lives of patients. We are seeking tenacious, compassionate, and collaborative individuals who are driven to make a positive impact.

Job purpose

AD is both a hands-on and a leadership role within technical operations in delivering analytical support for approved or pipeline products, mentoring, and coaching junior team members for professional growth, and developing best practice standardizing and streamlining operational procedures.

Responsibilities

• Lead, track, and document Analytical Development activities for approved or pipeline products

• Provide analytical support for Process Chemistry and Formulation Development as needed

• Manage and oversee all analytical laboratory functions at CMOs in support of assigned compounds or products

• Conduct analytical technical review of QC data generated at CMOs for release, stability, method validations, etc.

• Work with CMOs to develop appropriate strategies and methodologies for analytical method validation, stability studies, and batch release testing for maximum efficiency.

• Manage the transfer and/or validation of analytical methods to CMOs and independent contract testing laboratories. Provide ongoing analytical assistance to CMOs (e.g., method change or optimization)

• Lead the development and management of stage appropriate stability programs

• Lead the establishment and justification of all specifications for drug substances and drug products

• Provide analytical expertise for deviations and OOS/OOT investigations in concert with Quality Assurance to ensure proper disposition of affected materials

• Draft necessary technical paragraphs in IND/IMPD/CTD supporting global CMC regulatory submissions

• Interface effectively with other disciplines (e.g., Quality Assurance, Reg-CMC, Analytical Chemistry/DMPK, Process Chemistry, and Formulation Development)

• Support operational budgets, cost controls and resource planning to meet corporate strategic objectives

• Represent Analytical Development (AD) at interdepartmental meetings

Qualifications

• Advanced degree in Analytical Chemistry or related discipline with 8+ years of pharmaceutical development industry experience in AD, as well as Quality Control (QC)

• Demonstrated record of excellence, in leadership and management of AD/QC activities in a small molecule drug development industry environment

• Experienced in leading AD/QC teams in support of commercial and development stages projects

• Expert knowledge and hands-on experience with chromatographic methods and modern analytical instrumentation

• Highly organized and self-motivated

• Excellent interpersonal communication and decision-making skills

• Expert knowledge of cGMP compliance, ICH guidelines, compendial standards, and HA regulations pertaining to pharmaceutical manufacturing, method validations, product specifications, stability programs and other QC/AD activities

• Demonstrated ability to manage external contractors to meet or exceed Company goals

• Proficient in writing technical reports and AD/QC sections of CMC regulatory documents

• Demonstrated ability to effectively manage multiple products and projects

• Experience in creating, searching, and retrieving records in an Electronic Notebook system

Pay Range:

In the U.S., the hiring pay range for fully qualified candidates is $185,000-$226,000 per year. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors.

Our employees come from different backgrounds, and we celebrate those differences. We are looking for the best candidates for our open roles, but do not expect applicants to meet every qualification in order to be considered. If you are excited about what you could accomplish at Cytokinetics and believe you can add value to our team, we would love to hear from you.