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Associate Director – Project Management
East Brunswick
Associate Director – Project Management
East Brunswick
POSITION TITLE:
Associate Director – Project Management
DEPARTMENT:
Business Development
WORK LOCATION:
East Brunswick
EXPERIENCE:
5 Years
REPORTS TO:
COO
POSITION TITLE:
Associate Director – Project Management
EXPERIENCE:
5 Years
DEPARTMENT:
Business Development
REPORTS TO:
COO
WORK LOCATION:
East Brunswick
POSITION SUMMARY
Provide an overview of the role, including job scope / responsibilities, impact, decision authority, problem solving, level of influence, etc.
This position will work closely with management to continue to build the company’s portfolio through project management, negotiating, contracting, financial assessment, diligence, and portfolio management.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Identifying cost optimization opportunities.
- Create a request for proposal for all product transfer opportunities, evaluate proposals, and making a recommendation to the management.
- Work with management and legal team in creating term sheets, and review/modify business agreements for new portfolio additions, transfers, and 3rd parties.
- Screen new products for portfolio selection and seek management approval to add to the pipeline. Provide guidance during new product launches.
- Identify new API sources for all new products.
- Identify opportunities with new partners and diligence contracts alongside cross-functional stakeholders (e.g., legal, technical, regulatory, finance etc), and execute deals/transition them to the business for successful integration.
- Manage all 3rd party developments with CMOs.
- Collaborate with the R & D team to identify product requirements, procure product, and coordinate product shipment. Create and maintain R&D budgets and review/approve all R&D invoices.
- Coordinate industry conferences and meetings (CPHI and DCAT)
POSITION REQUIREMENTS
Experience
- Bachelor’s degree required, and an MBA is highly preferred. At least eight (8) years of relevant experience, which includes at least five (5) years within a generic pharmaceutical’s environment.
FUNCTIONAL KNOWLEDGE
Specialized Training or Technical Knowledge Licenses, Certifications Needed
- Familiarity with industry data sources and other pharmaceutical databases required
COMPANY / INDUSTRY RELATED KNOWLEDGE
- Thorough understanding of key steps in generic drug development, approvals and commercialization
JOB-SPECIFIC COMPETENCIES
- Demonstrated communication, information, project management and organizational skills.
- Strong computer and analytical skills.
- Familiarity with the generic drug development process preferred.
- Strong analytical skills and ability to interpret information from various sources.
- Advanced Excel skills and experience in financial analysis.
- Strong PowerPoint and presentation skills.
- Superior communication (spoken and written) skills.
Disclaimer
The list under Essential Functions and Additional Responsibilities is not exhaustive, but merely the most accurate list for the current job. Management reserves the right to revise the job description and to require that other tasks be performed when the circumstances of the job change. This position description in no way states or implies that the responsibilities and tasks are the only responsibilities and tasks to be performed by the employee occupying this position. She/He will be required to follow any other instructions and to perform any other job-related duties as required by his/her supervisor/manager. Requirements stated are minimum levels of knowledge, skills and/or abilities to qualify for this position. To perform the duties and responsibilities of this position successfully, employee will possess the abilities and aptitudes to perform each task proficiently. Employment decisions, including promotions, transfers and others, are based on meeting all requirements and on organizational needs, the employee being in good standing (including lack of disciplinary actions), meeting all applicable performance standards and other non-discriminatory criteria. The methods of fulfilling requirements are subject to possible modification to reasonably accommodate qualified individuals with disabilities. THIS DOCUMENT DOES NOT CREATE AN EMPLOYMENT CONTRACT, IMPLIED OR OTHERWISE. WE MAINTAIN AN “AT WILL” EMPLOYMENT.
Director – Microbiology
Decatur, Illinois
Director – Microbiology
Decatur, Illinois
POSITION TITLE:
Director – Microbiology
DEPARTMENT:
Microbiology
EXPERIENCE:
2 Years
WORK LOCATION:
Decatur, Illinois
POSITION TITLE:
Director – Microbiology
EXPERIENCE:
2 Years
DEPARTMENT:
Microbiology
WORK LOCATION:
Decatur, Illinois
POSITION SUMMARY
The Microbiology Director ensures that all microbiological and environmental monitoring requirements are in compliance with cGMP standards, Food and Drug Administration (FDA), European Pharmacopoeia (EP), United States Pharmacopoeia (USP), AMMI, and ISO guidelines. Directs the organization standards as they apply to the department. Directs and oversees the compliance of the department and organization for internal product line and third-party customer line. Interacts with the customer and Agency officials during routine and nonroutine site inspections. Oversees that the staff is trained, troubleshoots microbiological testing problems, development and implementation of departmental procedures are conducted in accordance with SOP’s and methods and ensure SOP’s and Method’s meet Company and FDA standards.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Directs the supervision of all microbiological and environmental tests that are performed and reported in compliance with cGMP standards and in a timely manner.
- Overview, conducts, and/or delegates the final review and approval of environmental and microbiological test results including contract labs requirements before the documentation are forwarded to QA Batch Record reviewers.
- Oversee the review of compliance guidelines, industry trends, customer’s projects, validation efforts, and development efforts to ensure Microbiology/Environmental departments meet or exceed the minimum requirements.
- Represent the department and company in all Regulatory and customer audits.
- Oversee the timely completion of projects, CAPAs, and investigations.
- Oversee and assures that the departmental training program meets Company standards.
- Oversee and review responses compliance audits/deficiencies and CAPA plans of areas of responsibility.
- Oversee the coordination of development and validation of microbiological methods.
- Perform employee performance appraisals in a timely
- Oversee and conducts the hiring process of new personnel for the Microbiology and/or Environmental departments (Salary and Hourly).
- Oversee and/or ensures that all laboratory equipment are in compliance with company and regulatory
- Drives in conjunction with other departments and Rising sites the global application of compliance and operation.
Additional Responsibilities:
- Directly supervises the Microbiology and Environmental Monitoring Supervisors. Carries out management responsibilities in accordance with the organization’s policies and applicable laws. Planning, assigning, and directing work, appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems. Review of new and revised regulatory and guidance documents and processes/practices to assure continuous improvement and compliance.
POSITION REQUIREMENTS
Education and Experience:
- Bachelor’s Degree in Microbiology and seven years of experience in a Pharmaceutical Microbiology Laboratory under cGMP guidelines. Minimum of three years of management experience preferred. Experience should include exposure and understanding in the following areas: FDA, EP, ISO, AMMI regulations, current LISP and Supplement in Microbiological and Environmental requirements, Isolation and identification of Microbial Isolates, Aseptic Techniques, Gowning Techniques, Bioburden Test by MPN, Plate Count, and Membrane Filtration methods, Culture Maintenance and Record Maintenance, BF/Sterility testing, AET, BRT, and Environmental Monitoring Guidelines for Viable and Non-Viable Monitoring. An equivalent combination of education and experience may substitute.
Physical Demands, Mental requirements, and Work Environment
- While performing the duties of this job, the employee is regularly required to sit, stand, walk, talk and hear. The employee is required to use hands to finger, handle, or feel. Specific vision abilities required by this job include close vision for written work and PC use.
Mental Requirements
- Ability to hear accurately the spoken word with moderate office and plant noise;
- Ability to apply deductive reasoning and understand complicated issues;
- Ability to receive instructions and follow work rules and company policies;
- Ability to follow safety and security practices;
- Ability to meet deadlines and effectively deal with office stress;
- Ability to accurately communicate ideas, facts and technical information; and
- Maintain confidentiality of certain information.
JOB-SPECIFIC COMPETENCIES
- Ability to meet attendance standards. All full-time employees are required to work a minimum 40-hour week. At times it may be necessary to work additional hours to get the required tasks accomplished to meet deadlines.
- This individual must have an understanding of regulatory guidelines and/or compliance documents.
Disclaimer
The list under Essential Functions and Additional Responsibilities is not exhaustive, but merely the most accurate list for the current job. Management reserves the right to revise the job description and to require that other tasks be performed when the circumstances of the job change. This position description in no way states or implies that the responsibilities and tasks are the only responsibilities and tasks to be performed by the employee occupying this position. She/He will be required to follow any other instructions and to perform any other job-related duties as required by his/her supervisor/manager. Requirements stated are minimum levels of knowledge, skills and/or abilities to qualify for this position. To perform the duties and responsibilities of this position successfully, employee will possess the abilities and aptitudes to perform each task proficiently. Employment decisions, including promotions, transfers and others, are based on meeting all requirements and on organizational needs, the employee being in good standing (including lack of disciplinary actions), meeting all applicable performance standards and other non-discriminatory criteria. The methods of fulfilling requirements are subject to possible modification to reasonably accommodate qualified individuals with disabilities. THIS DOCUMENT DOES NOT CREATE AN EMPLOYMENT CONTRACT, IMPLIED OR OTHERWISE. WE MAINTAIN AN “AT WILL” EMPLOYMENT.
QA Technician – Grand
Decatur, Illinois
QA Technician – Grand
Decatur, Illinois
POSITION TITLE:
QA Technician – Grand
DEPARTMENT:
Quality Assurance
REPORTS TO:
Senior Manager Quality Assurance – Operations
WORK LOCATION:
Decatur, Illinois
POSITION TITLE:
QA Technician – Grand
DEPARTMENT:
Quality Assurance
REPORTS TO:
Senior Manager Quality Assurance – Operations
WORK LOCATION:
Decatur, Illinois
POSITION SUMMARY
- The QA Technician performs quality assurance duties to prevent or eliminate defects in products for sterile filling operation or in final inspection and packaging operations. This individual must work in a detail-oriented, compliant manner in a high stress environment where adherence to deadlines is critical. The individual must display exemplary level of integrity at all times.
- Manage a workload of varying priorities while adhering to strict deadlines.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Monitor the production process and ensure consistency of procedures.
- Perform visual inspection of finished product.
- Perform AQL testing of finished product.
- Review in process documentation.
- Audit manufacturing rooms for adherence to cGMP and SOPs
- Audit the maintenance of a clean and sanitary environment.
- Review daily/weekly/monthly and bi-monthly logbook entries for completeness.
- Review, approve and issue verified -clean green release stickers to operations.
- Check machine settings.
- Observe/mentor personnel on aseptic performance.
Perform line clearances and review documentation (circular charts, autoclave tapes etc.) to allow operations to initiate production (release to fill). - Obtain and maintain gown certification for clean room entry.
POSITION REQUIREMENTS
Education and Experience:
- Associates Degree or equivalent from a two- year college or technical school; or one year related experience and/or training; or equivalent combination of education and experience.
Physical Demands, Mental requirements, Work Environment and Safety Requirements
- While performing the duties of this job, the employee is regularly required to sit, stand, walk, talk, and hear. The employee is required to use hands to finger, handle, or feel. Specific vision abilities required by this job include close vision for written work and PC use.
- Safety glasses, close-toed shoes, and latex gloves are required in many areas within the facility
Mental Requirements
- Ability to write, read, and apply technical scientific writing, procedures, and quality policies.
- Ability to work independently in an efficient and detail-oriented manner.
- Ability to work on multiple projects and priorities in a concurrent manner.
- Ability to work in an independent manner, as well as a group environment.
- Ability to apply deductive reasoning and analytical thought to understand complicated issues.
- Ability to receive instructions and follow work rules and company policies.
- Ability to follow safety and security practices.
- Ability to meet deadlines and effectively deal with a high level of office stress.
- Ability to maintain confidentiality of work assignments and personnel issues.
JOB-SPECIFIC COMPETENCIES
- Ability to meet attendance standards. All full-time employees are required to work a minimum 40-hour week. At times it may be necessary to work additional hours to get the required tasks accomplished to meet deadlines.
- Must have a complete knowledge of current Good Manufacturing Practices, United States Pharmacopeia, current Code of Federal Regulations (21 CFR parts 11, 210, 211, 820), and other FDA regulations and guidances.
- Have general math skills: adding, subtracting, multiplication, division, and percentage calculation. Ability to calculate figures and amounts such as discounts, interest, commissions, and proportions.
- Able to use personal computer and standard office equipment such as fax and copy machines, calculators, and printers. Aptitude to learn computer programs as needed (i.e. Microsoft Office Word, Excel) in addition to other business applications.
- Strong verbal and written communication skills. Resourceful and well organized.
- Ability to read and interpret standard documents such as: procedure manuals, employee handbook, and job related publications. Ability to write routine reports and correspondence.
- Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
Disclaimer
The list under Essential Functions and Additional Responsibilities is not exhaustive, but merely the most accurate list for the current job. Management reserves the right to revise the job description and to require that other tasks be performed when the circumstances of the job change. This position description in no way states or implies that the responsibilities and tasks are the only responsibilities and tasks to be performed by the employee occupying this position. She/He will be required to follow any other instructions and to perform any other job-related duties as required by his/her supervisor/manager. Requirements stated are minimum levels of knowledge, skills and/or abilities to qualify for this position. To perform the duties and responsibilities of this position successfully, employee will possess the abilities and aptitudes to perform each task proficiently. Employment decisions, including promotions, transfers and others, are based on meeting all requirements and on organizational needs, the employee being in good standing (including lack of disciplinary actions), meeting all applicable performance standards and other non-discriminatory criteria. The methods of fulfilling requirements are subject to possible modification to reasonably accommodate qualified individuals with disabilities. THIS DOCUMENT DOES NOT CREATE AN EMPLOYMENT CONTRACT, IMPLIED OR OTHERWISE. WE MAINTAIN AN “AT WILL” EMPLOYMENT.
Quality Control Chemist
Decatur, Illinois
Quality Control Chemist
Decatur, Illinois
POSITION TITLE:
Quality Control Chemist
DEPARTMENT:
Quality Control
REPORTS TO:
Supervisor of Quality Control
WORK LOCATION:
Decatur, Illinois
POSITION TITLE:
Quality Control Chemist
DEPARTMENT:
Quality Control
REPORTS TO:
Supervisor of Quality Control
WORK LOCATION:
Decatur, Illinois
POSITION SUMMARY
Perform the sampling of raw materials, chemical and physical analysis of raw material, bulk formulations, finished products, stability samples, and any non-routine samples.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Sampling and testing of raw materials per approved procedure.
- Physical and chemical testing of bulk and (pre-fill, finished product, and stability) product.
- Upkeep of laboratory notebook.
- Maintaining the work area in an orderly manner.
- Maintaining Lab inventory like list of standards, chemical, reagent etc.
- Recording daily activity like PH verification, balance verification, temperature and humidity monitoring of lab stability chambers, freezer, refrigerator etc.
- Experience in the operation of handling QC major instruments like HPLC, GC, UV, IR, Auto titrator, etc.
- Perform Finished product/in-process/cleaning validation and raw material analysis independently. Complete testing within specified timeframes and document results accurately
- Coordinate with vendor for instrument PM, calibration and qualification activity. Provide necessary support.
- Maintain and monitor lab GLP activity like instrument calibration/qualification schedule, Preparation of instrument operating procedure, coordinate with metrology team and vendor for scheduling period calibration/qualification activity etc.
- Performs calibration of lab instruments whenever possible.
- Cleaning of laboratory glassware.
- Responsible for writing SOP for instrument operation/ calibration etc.
- Provide necessary support for OOS/OOT investigation.
- Preparation of stability schedule, Protocol, and report per ICH requirements.
- Adhere to regulatory guidelines (e.g., FDA, ICH, GMP) and company quality standards during testing and documentation.
- Ensure adherence to Good Laboratory Practices (GLP), Good Documentation Practices (GDP), and Good Manufacturing Practices (GMP) during testing procedure.
POSITION REQUIREMENTS
Education and Experience
- Bachelor’s Degree from a four-year accredited college or university with a Major in Chemistry or equivalent.
- Prefer, two years of industry experience involving analytical or wet chemistry test procedures in a quality control environment.
- Experience with, Infra-Red (IR), Ultraviolet/Visible Spectroscopy, Particle Size Analysis, KF Titration, and wet chemistry skills are required.
- Familiarity with High Pressure Liquid Chromatography, Gas Chromatography (GC), and HPLC/GC analytical software is preferred, but not required.
- Familiarity with GLP/GMP guidelines.
- Good Communication and writing skills.
- Familiarity with out-of-specification (OOS) investigation.
- Computer literate.
- Experience with USP/EP monographs.
FUNCTIONAL KNOWLEDGE
Knowledge
- Bachelor of Science Degree in Chemistry, Engineering, Microbiology, or a related field and three (3) years’ experience in the pharmaceutical industry, or equivalent experience
COMPANY / INDUSTRY RELATED KNOWLEDGE
Knowledge
- cGMP, DEA, and OSHA compliance
JOB-SPECIFIC COMPETENCIES
- Ability to meet attendance standards.
- At times it may be necessary to work additional hours to get the required tasks accomplished to meet deadlines.
- Working knowledge of MS Word, Excel, Outlook, and Power Point.
- Working knowledge of Adobe Acrobat.
- Excellent conceptualizing, analytical, and problem-solving skills.
Disclaimer
The list under Essential Functions and Additional Responsibilities is not exhaustive, but merely the most accurate list for the current job. Management reserves the right to revise the job description and to require that other tasks be performed when the circumstances of the job change. This position description in no way states or implies that the responsibilities and tasks are the only responsibilities and tasks to be performed by the employee occupying this position. She/He will be required to follow any other instructions and to perform any other job-related duties as required by his/her supervisor/manager. Requirements stated are minimum levels of knowledge, skills and/or abilities to qualify for this position. To perform the duties and responsibilities of this position successfully, employee will possess the abilities and aptitudes to perform each task proficiently. Employment decisions, including promotions, transfers and others, are based on meeting all requirements and on organizational needs, the employee being in good standing (including lack of disciplinary actions), meeting all applicable performance standards and other non-discriminatory criteria. The methods of fulfilling requirements are subject to possible modification to reasonably accommodate qualified individuals with disabilities. THIS DOCUMENT DOES NOT CREATE AN EMPLOYMENT CONTRACT, IMPLIED OR OTHERWISE. WE MAINTAIN AN “AT WILL” EMPLOYMENT.
