Manager, Analytical Development jobs in United States
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Curia · 15 hours ago

Manager, Analytical Development

Curia is a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering with pharmaceutical and biotech companies to provide life-saving treatments to patients. The Manager, Analytical Development will assist with analytical development efforts and lead a team of scientists to ensure project objectives are met in a timely and efficient manner.

BiotechnologyHealth CareManufacturing
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H1B Sponsor Likelynote

Responsibilities

Oversee stability program, including authoring protocols, pulling samples, scheduling of assays, data review and summary reports
Well versed on performing USP compendial testing of biologics (appearance, pH, conductivity, osmolality, UV, subvisible particles, endotoxin)
Familiar with assays to characterize proteins such as ELISA, cIEF, CE-SDS reduced/nonreduced, SEC-HPLC
Familiar with assays to characterize RNA such as Sequence, intactness, capping efficiency, poly(A) tail length, ds RNA impurity, aggregates, %fragments, residual DNA, free nucleosides
Familiar with cell based assays
Provide leadership and management within the department and other groups as assigned through a structural process of objective setting, performance appraisal, mentoring and individual development as appropriate
Lead a group of scientists through multiple pharmaceutical development projects
Responsible for improving the overall department productivity, efficiency, and profitability, as well as individual performance and group collaboration
Carry out an active laboratory analytical program, managing samples, validation of procedures and/or equipment as necessary, and be able to solve the more complex analytical problems that arise within the group
Well versed in ICH guidelines for method validation
Design, develop, validate and implement IND-enabling analytical solutions, including testing procedures, specifications, protocols and reports
Ensure that the lab functions are completed in accordance with the Company and governmental standards of safety and quality, and that all experimental documentation is complete and timely
Act as the technical leader and analytical expert, and interact with external customers and internal colleagues. Will be responsible for providing liaison communication with key members of client organizations
Supervise a team of scientists including, but not limited to, the motivation, education, efficiency, performance management and productivity of these individuals
Allocate the section’s resources in accord with project priorities within guidelines set by corporate management
Communicate effectively in both verbal and written form on results, issues and plans. This may involve and include close interactions with customers
Ensure that laboratory operations are conducted in a safe manner. Remain familiar with the contents of the Chemical Hygiene Plan. Follow safety rules fully
Recommend and implement methods and techniques to increase the quality of products and/or service
Exhibit safety awareness and safe work practices

Qualification

Compendial analytical technologiesBiological assays ICH validationTeam leadershipAnalytical Chemistry degreeStatistical analysisSafety awarenessCommunication skillsProblem-solving skills

Required

High School diploma or GED and a minimum of 9 years of relevant related work experience, plus 2 years in a team leadership role of professional level individual contributors, OR
AS Degree in Analytical Chemistry or related field and a minimum of 7 years of relevant related work experience, plus 2 years in a team leadership role of professional level individual contributors, OR
BA/BS Degree in Analytical Chemistry or related field and a minimum of 5 years of relevant related work experience, plus 2 years in a team leadership role of professional level individual contributors, OR
MA/MS Degree in Analytical Chemistry or related field and a minimum of 3 years of relevant related work experience, plus 2 years in a team leadership role of professional level individual contributors
Expert in compendial analytical technologies
Extensive knowledge and working experience in biological assays per ICH method validation
Excellent written and oral communication skills
Ability to apply concepts such as fractions, percentages, ratios, statistics and proportions to practical situations
Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems
Ability to deal with nonverbal symbolism (formulas, scientific equations, graphs, etc.) in its most difficult phases
Ability to deal with a variety of abstract and concrete variables

Preferred

Direct experience in drug substance development

Benefits

Generous benefit options (eligible first day of employment)
Paid training, vacation and holidays (vacation accrual begins on first day of employment)
Career advancement opportunities
Education reimbursement
401K program with matching contributions
Learning platform
And more!

Company

Curia is a biotechnology company that offers discovery biology, synthetic, medicinal chemistry, and small-scale manufacturing services.

H1B Sponsorship

Curia has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (34)
2024 (17)
2023 (8)

Funding

Current Stage
Late Stage
Total Funding
unknown
2025-03-07Debt Financing
2017-08-31Private Equity

Leadership Team

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Steve Lavezoli
Vice President, Biologics Division
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Company data provided by crunchbase