Senior Manager, Analytical Development
Apply NowCompany: Axsome Therapeutics, Inc.
Location: New York, NY 10025
Description:
Axsome Therapeutics, Inc. is a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders. The Axsome team is a lean, dynamic group of individuals committed to addressing unmet needs for patients with CNS disorders. Axsome is based in New York City.
About This Role
Axsome Therapeutics is seeking a Senior Manager of Analytical Development to manage and coordinate analytical activities on multiple early and/or late phase clinical development programs. The ideal candidate will be a team player comfortable working on a small team in a fast-paced environment and with contract manufacturing and development organizations. Excellent time management skills and communication will be key in succeeding in this role. This position is non-laboratory based and prior hands-on laboratory experience using a broad array of analytical instrumentation is a requirement.
This role is based at Axsome's HQ in New York City with an on-site requirement of at least three days per week. We are unable to consider candidates who are looking for fully remote roles.
Job Responsibilities and Duties include, but are not limited to, the following:
Work closely with the CMC team (and specifically the head of analytical development) to manage and coordinate analytical activities on multiple early to mid-phase drug substance and drug product small molecules, with experience in solid oral formulation programs
Manage early and/or late phase drug substance and drug product analytical activities at contract development laboratories (method development, method qualifications/validations, method transfers, analytical investigations support)
Review and/or author analytical technical/development and method qualification/validation reports and raw data as well as release and stability data packages
Authoring of CMC sections for regulatory submissions
Manage drug substance and drug product stability programs (QC and technical review of stability data packages, including stability data trending)
Assist in the development of analytical development related policies and standard operating procedures
Manage reference materials and reference standards inventory and (re)qualification testing
Requirements / Qualifications
MS or PhD in Analytical Chemistry, Chemistry, Biology or related field with 7 years of GMP and GLP-related pharmaceutical industry experience in small molecule solid oral formulation analytical development
Knowledge of drug product solid oral dose formulations
Hands-on experience with drug substance and drug product analytical techniques such as HPLC, GC, KF, MS, dissolution, spectroscopy, and particle size
Functional understanding of small molecule analytical development and associated regulatory and quality requirement
In-depth understanding of GMPs and applicable CMC, analytical and manufacturing regulatory guidance
Ability to work on site Monday, Tuesday & Thursday
Experience, Knowledge and Skills
Demonstrated experience in managing outsourced analytical vendors and activities
Demonstrated experience in QC data review of release and stability data packages for both drug substance and drug product
Experience working on late stage/commercial stage products highly valued
Excellent verbal and written communication skills
Excellent problem solving and interpersonal skills
Exceptional organizational skills with the ability to multi-task and prioritize workload based upon changing priorities
Ability to work in a cross-functional team environment and to be a team player as well as the ability to work independently
Flexibility to accommodate multiple time zones as needed
Preference to energetic candidates with a desire to think "outside the box"
Willingness to travel periodically as needed
Salary & Benefits
The anticipated salary range for this role is $120,000 - $150,000. We encourage candidates of all levels to apply as there may be flexibility on final job title and responsibilities. The salary offer will be based on a variety of factors, including experience, qualifications, internal equity and location. Axsome offers a competitive employment package that includes an annual bonus, significant equity and a generous benefits package.
Axsome is committed to equal employment opportunity and providing reasonable accommodations to applicants with physical and/or mental disabilities. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, gender, sex, age, religion, creed, national origin, sexual orientation, gender identity, ancestry, citizenship, marital status, physical or mental disability, medical condition, veteran status, genetic information, or any other characteristic protected by federal, state, or local law.
Axsome Therapeutics does not accept unsolicited resumes from recruiters or third-party recruitment agencies and will not pay placement fees for unsolicited candidates that are sent to hiring managers, the HR team or other Axsome team members. Only approved vendors who have been explicitly asked to support a specific search will receive access to our Applicant Tracking System to submit candidates for consideration.
About This Role
Axsome Therapeutics is seeking a Senior Manager of Analytical Development to manage and coordinate analytical activities on multiple early and/or late phase clinical development programs. The ideal candidate will be a team player comfortable working on a small team in a fast-paced environment and with contract manufacturing and development organizations. Excellent time management skills and communication will be key in succeeding in this role. This position is non-laboratory based and prior hands-on laboratory experience using a broad array of analytical instrumentation is a requirement.
This role is based at Axsome's HQ in New York City with an on-site requirement of at least three days per week. We are unable to consider candidates who are looking for fully remote roles.
Job Responsibilities and Duties include, but are not limited to, the following:
Work closely with the CMC team (and specifically the head of analytical development) to manage and coordinate analytical activities on multiple early to mid-phase drug substance and drug product small molecules, with experience in solid oral formulation programs
Manage early and/or late phase drug substance and drug product analytical activities at contract development laboratories (method development, method qualifications/validations, method transfers, analytical investigations support)
Review and/or author analytical technical/development and method qualification/validation reports and raw data as well as release and stability data packages
Authoring of CMC sections for regulatory submissions
Manage drug substance and drug product stability programs (QC and technical review of stability data packages, including stability data trending)
Assist in the development of analytical development related policies and standard operating procedures
Manage reference materials and reference standards inventory and (re)qualification testing
Requirements / Qualifications
MS or PhD in Analytical Chemistry, Chemistry, Biology or related field with 7 years of GMP and GLP-related pharmaceutical industry experience in small molecule solid oral formulation analytical development
Knowledge of drug product solid oral dose formulations
Hands-on experience with drug substance and drug product analytical techniques such as HPLC, GC, KF, MS, dissolution, spectroscopy, and particle size
Functional understanding of small molecule analytical development and associated regulatory and quality requirement
In-depth understanding of GMPs and applicable CMC, analytical and manufacturing regulatory guidance
Ability to work on site Monday, Tuesday & Thursday
Experience, Knowledge and Skills
Demonstrated experience in managing outsourced analytical vendors and activities
Demonstrated experience in QC data review of release and stability data packages for both drug substance and drug product
Experience working on late stage/commercial stage products highly valued
Excellent verbal and written communication skills
Excellent problem solving and interpersonal skills
Exceptional organizational skills with the ability to multi-task and prioritize workload based upon changing priorities
Ability to work in a cross-functional team environment and to be a team player as well as the ability to work independently
Flexibility to accommodate multiple time zones as needed
Preference to energetic candidates with a desire to think "outside the box"
Willingness to travel periodically as needed
Salary & Benefits
The anticipated salary range for this role is $120,000 - $150,000. We encourage candidates of all levels to apply as there may be flexibility on final job title and responsibilities. The salary offer will be based on a variety of factors, including experience, qualifications, internal equity and location. Axsome offers a competitive employment package that includes an annual bonus, significant equity and a generous benefits package.
Axsome is committed to equal employment opportunity and providing reasonable accommodations to applicants with physical and/or mental disabilities. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, gender, sex, age, religion, creed, national origin, sexual orientation, gender identity, ancestry, citizenship, marital status, physical or mental disability, medical condition, veteran status, genetic information, or any other characteristic protected by federal, state, or local law.
Axsome Therapeutics does not accept unsolicited resumes from recruiters or third-party recruitment agencies and will not pay placement fees for unsolicited candidates that are sent to hiring managers, the HR team or other Axsome team members. Only approved vendors who have been explicitly asked to support a specific search will receive access to our Applicant Tracking System to submit candidates for consideration.