Analytical Transfer Lead

Noramco is a leading specialty active pharmaceutical ingredient (API) development and manufacturing company that supports the advancement of opioid and non-opioid products in a range of therapeutic applications. Founded in 1979, the company is headquartered in Delaware and maintains operations around the world.

Specialists in controlled substance development and manufacturing, Noramco is a partner to the pharmaceutical industry:

– Delivering DEA-compliant security and production capacity, from kilos to multi-ton supply
– High-purity controlled substances from narcotic raw materials
– Formulation-friendly particle size grades and extended technical packages
– Supporting world-class supply security of controlled substances, from schedule I to schedule III

https://www.noramco.com/

GENERAL PURPOSE OF JOB

The Analytical Transfer Lead (“ATL”) is an analytical development SME within the program management team. The ATL is responsible for overseeing analytical method transfer and/or validation to ensure compliance with cGMP and regulatory expectations. In addition, the ATL is responsible for owning the reference standard inventories for all active projects.

ESSENTIAL DUTIES AND RESPONSIBILITIES

· Support Program Managers for all analytical activities including method transfer and/or validation internally and externally for assigned program(s)

· Author or review protocols and reports for method transfer and/or method validation or method bridging, and other technical development reports associated with methods

· Plan and track method transfer and/or method validation deliverables

· Collaborate and interact with internal and external QC manufacturing and testing sites, program managers and functional area project representation

· Review method transfer and/or method validation assays, perform data verification, non-routine data mining, and in-depth data analysis

· Represent external manufacturing analytical in intra-department project/initiative or cross-functional teams in support of program and company objectives

· Perform other appropriate duties as assigned.

ADDITIONAL POSITION REQUIREMENTS

· Must be able to work autonomously and anticipate and resolve problems with little assistance or direction.

· Must be able to produce high quality and accurate work in a timely manner to meet the project schedule.

· Must be able to communicate information timely in a clear concise manner.

· Must be able to convey technical information to non-technical audiences.

· Manage and coordinate multiple project priorities and work effectively across the organization in completing projects on time and in budget.

· 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.

· Follow all applicable aspects of the site Environmental Management System as it pertains to normal job duties.

· Successfully complete regulatory and job training requirements.

· Comply with safety rules, policies and practices with the intent to maintain a safe working environment. Report all safety incidents, accidents or injuries to supervisor immediately.

· Be available for overtime work on a scheduled or emergency basis.

· Up to 20% travel may be required for introductions at other facility locations.

· Other projects or assignments as requested by management.

SUPERVISORY RESPONSIBILITIES - none

EDUCATION and/or EXPERIENCE

Bachelor Science Analytical Chemistry preferred or related field with 3-6 years working experience in the pharmaceutical or biotech industry is required. Must have the ability to understand and apply knowledge of pharmaceutical active ingredient manufacturing, drug development, drug technology, and project management processes. Experience working with controlled substances is preferred. Previous experience with cGMPs in a FDA regulated site, process safety practices and environmental standards required.

LANGUAGE SKILLS

· Read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.

· Write reports, business correspondence, and procedures.

· Effectively present information and respond to questions

· Technical writing skills

MATHEMATICAL SKILLS

· Apply mathematical concepts such as exponents, logarithms, quadratic equations, and permutations.

· Understands the utilization of control charts and statistical process control.

REASONING ABILITY

· Interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

· Define problems, collect data or information, establish facts and draw valid conclusions.

OTHER SKILLS ABILITIES OR QUALIFICATIONS

· Must be able to work effectively with others and with minimal supervision.

· Manage and coordinate multiple project priorities.

· Attention to detail is a must

· Must exhibit patience- Ability to listen and check before acting. Is tolerant with people and processes, tries to understand the people and the data before making judgments and acting, sensitive to due process and proper approaches.

· Strong computer skills with hands on experience with MS Office (Excel, Word, Project, etc.)

PHYSICAL DEMANDS

· While performing the duties of this job, the employee is frequently required to stand; walk; use hands to finger, handle, or feel.

· The employee is occasionally required to sit; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl.

· The employee must occasionally lift and/or move up to 10 pounds.

· Specific vision abilities required by this job include close vision, color vision, and ability to adjust focus.

Noramco provides 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: $70,000.00 - $80,000.00 per year

Benefits:

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

Schedule:

• Monday to Friday

Work Location: Hybrid remote in Wilmington, DE 19801

Salary : $70,000 - $80,000