Associate Director CMC Analytical Chemistry
Associate Director CMC Analytical Chemistry
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$ 185000 - 226000
1 Vacancy
Job Description
Cytokinetics is a latestage specialty cardiovascular biopharmaceutical company focused on discovering developing and commercializing firstinclass muscle activators and nextinclass 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 handson 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 RegCMC 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 handson experience with chromatographic methods and modern analytical instrumentation
Highly organized and selfmotivated
Excellent interpersonal communication and decisionmaking 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 $185000$226000 per year. The base pay actually offered will take into account internal equity and also may vary depending on the candidates geographic region jobrelated 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.
Please review ourGeneral Data Protection Regulation (GDPR) policyPRIOR to applying.
Our passion is anchored in robust scientific thinking grounded in integrity and critical thinking. We keep the patient front and center in all we do all actions and decisions are in service of the patient and their caregivers. We champion integrity ethics doing the right thing and being our best selves.
Fraud Warning: How to Identify Impersonated Cytokinetics Job Postings and Offers
Recently there have been fraudulent employment offers being sent to candidates on behalf of Cytokinetics. Please be advised that all legitimate offers from Cytokinetics will come directly from our official email domain and will only be made after completing a formal interview process.
Here are some ways to check for authenticity:
We do not conduct job interviews through nonstandard text messaging applications
We will never request personal information such as banking details until after an official offer has been accepted and verified
We will never request that you purchase equipment or other items when interviewing or hiring
If you are unsure about the authenticity of an offer or if you receive any suspicious communication please contact us directly at
Cytokinetics is an Equal Opportunity Employer
Required Experience:
Director
Employment Type
Full-Time
