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Manager, Process R D Purisys - 3.0 Athens, GA Job Details Full-time $130,000 - $160,000 a year 1 day ago Benefits Health savings account Health insurance Dental insurance Flexible spending account Paid time off Employee assistance program Vision insurance 401(k) matching Life insurance Referral program Qualifications Customer service Personal protective equipment (PPE) adherence Team development Hiring Doctor of Philosophy Chemical new product development projects Research & development FDA regulations Full Job Description Purisys LLC d/b/a Siegfried Acceleration Hub Athens is a trusted CDMO partner for custom pharmaceutical API and other chemical synthesis projects with capabilities unique in the industry. Built over a 40-year history, our expertise allows us to support a diverse range of custom API development projects from proof of concept, bench chemistry to full-scale product commercialization - with particular strengths in full-service clinical Phase I/II and small volume, orphan drug commercial API GMP synthesis. Our broad ranging, and often specialized, chemistry capabilities make us the partner of choice for technically intensive and complex projects. Purisys also has an industry-leading track record in compliance with US FDA cGMPs and other global regulatory bodies. For more information on the company please visit https://www.siegfried.ch/ GENERAL

PURPOSE OF JOB

Leads the process R D function responsible for developing and implementing new processes and improving existing processes for commercial, developmental, and reference standards manufacturing. Assists the business development team by evaluating the technical feasibility of manufacturing new products or supporting technical transfers of products to Athens or external manufactures.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Responsible for the safety, health and wellbeing of all employees and contractors working in the R D Laboratory areas in Athens. Provides guidance and work direction to department employees. Responsible for the development and leadership of employees in Process R D Group. Is responsible for managing the performance of employees to include involvement in processes such as objective setting, performance reviews, staffing, corrective action, succession planning, training and development, and other key human resource management activities. Responsible for the overall performance of the Process R D Group. Responsible for ensuring that key projects for development and process technical transfer are identified, initiated, and executed in a timely fashion. Responsible for the technical evaluations of customer requests for proposals with attention to scope, timing, and safety of performing the work in Athens laboratories and plant. Plans, performs and reports laboratory work in support of developing new processes, or generating information to support process validation and regulatory filings. Develops and proposes new methodologies and evaluates new technologies in order to reduce cost and improve overall process efficiencies. Provides technical support and expertise to both internal and external customers such as Production, Process Engineering, Regulatory, Quality, EHS and third-party customers and partners. Guides, reviews and approves research development reports, as well as documentation associated with process validation and production records. Writes technical protocols, reports, procedures, specifications and regulatory documents using scientific and compliant style. Responsible for identifying cost savings/avoidance opportunities where appropriate.

ADDITIONAL POSITION REQUIREMENTS

Successfully completes regulatory and job training requirements. Understands and responsibly performs duties with attention to quality, safety and environmental matters. Items include; wearing appropriate personal protective equipment, recognizing, reporting and appropriately responding to hazards in the work area (spills/accidents/near misses), maintaining proper housekeeping at all times, properly labeling and storing chemicals, plus all other relevant job requirements. Assumes responsibility for the environmental effects of work performed for the identification and recording of environmental problems as they arise. Follows all applicable aspects of the site Environmental Management System as it pertains to normal job duties. Carries out duties in compliance with all state and federal regulations and guidelines including FDA, EPA, OSHA and DEA. Complies with all company and site policies and procedures. Must be available to work overtime on a scheduled or emergency basis. Remains current in skills and industry trends. Is available to travel nationally and internationally to undertake the role. Is available for other duties as required.

SUPERVISORY RESPONSIBILITIES

Supervises the Process R D Group employees at the Athens, GA. Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems. Responsible for regulatory compliance (DEA, OSHA, cGMP) in the R D laboratories. EDUCATION and/or

EXPERIENCE

Minimum requirements include: Doctoral degree (Ph.D.) with 8+ years of related experience in an R D laboratory and/or kilo lab/pilot plant with proven track record of process development of APIs. Prior experience supervising or managing others preferred. Commercial production experience and knowledge of GLP/cGMP regulations and ICH guidelines is highly preferred.

LANGUAGE SKILLS

Read, analyze, and interpret the moderately complex technical and regulatory documents. Regularly responds effectively to inquiries or complaints from client groups, customers and regulatory agencies. Ability to write moderately complex technical reports, business correspondence and technical procedural instructions/manuals. Creates presentations using original or innovative techniques, as well as established template formatting. Ability to effectively present information and respond to questions from groups of managers, employees, top management, public groups, and/or boards of directors. Makes effective and persuasive presentations on moderately controversial or complex topics.

MATHEMATICAL SKILLS

Apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations. Apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis. Apply principles of logical or scientific thinking to a wide range of intellectual and practical problems. Deal with nonverbal symbolism (formulas, scientific equations, graphs, etc.,) in highly complex phases.

REASONING ABILITY

Apply principles of logical or scientific thinking to a wide range of intellectual and practical problems. Deal with nonverbal symbolism (formulas, scientific equations, graphs, etc.,) in its most difficult phases. Deal with a variety of abstract and concrete variables.

OTHER SKILLS ABILITIES OR QUALIFICATIONS

Expert knowledge of organic chemistry and cGMP regulations. Demonstrated successful experience with chemical process development, process scale-up and transfer of processes to commercial production.

Knowledge of modern analytical techniques:

HPLC, GC, NMR, XRPD, Particle Size Analysis and interpretation of data from these techniques Use computer software and customized programs to meet business needs, including word processing and mathematical applications. Must be able to work with people, influencing their output and work behavior. Must be able to work in situations where speed and sustained attention are essential, performing a variety of tasks without loss of production.

PHYSICAL DEMANDS

While performing the duties of this job, the employee is frequently required to stand; walk; sit; reach with hands and arms, use hands to finger, handle, or feel. Must have fine motor skills to perform precise laboratory manipulations. The employee is occasionally required to: climb or balance; stoop, kneel, crouch, or crawl. The employee must regularly lift and/or move up to 10 pounds; occasionally lift and/or move up 40 pounds. Specific vision abilities required by this job include close vision, peripheral vision, depth perception, color vision, and ability to adjust focus. Must be able to qualify for respiratory protective equipment use and must be able to smell surrounding environments. We provide opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

Job Type:

Full-time Pay:

$130,000.00 - $160,000.00 per year

Benefits:

401(k) matching Dental insurance Employee assistance program Flexible spending account Health insurance Health savings account Life insurance Paid time off Referral program Vision insurance

Work Location:

In person