Manager, Analytical Development

Curia • Hopkinton, MA

8h

About The Position

The Manager, Analytical Development will assist with the analytical development efforts of multiple projects and will be responsible for guiding a productive analytical research and development for biological program. The incumbent may lead a team of professional scientists and efficiently manage scientific efforts and resources to ensure the attainment of objectives in a timely manner. The Manager must be able to effectively communicate results and issues within the projects to management and customers with the highest of professional standards.
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. At Curia, we are on a mission to advance our customers’ therapies from curiosity to cure and ultimately to improve patients’ lives.

Requirements

• 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
• Must pass a background check
• Must pass a drug screen
• May be required to pass Occupational Health Screening

Nice To Haves

• Direct experience in drug substance development

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

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

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Education Level: High school or GED