Duties and Responsibilities:

• Conducts chemical, chromatographic, dissolution and physical testing of raw materials, in-process and finished products, stability samples, and cleaning validation swabs to provide accurate and reliable data to assure their strength, identity, and purity.
• Contributes to development and validation of analytical methods.
• Maintains accurate and complete lab data notebooks.
• Records and reports results of analysis in accordance with prescribed lab procedures and systems.
• Recognizes and solves, with assistance, analytical and product problems.
• Reviews laboratory documentation for calculation, entry and GMP compliance.
• Documents and reports results of development and experimentation in technical reports.
• Participates and contributes to safety programs, performs instrument audits, and maintains an orderly and safe laboratory environment.

Requirements:

• Minimum of 5 years experience in an analytical chemistry laboratory, including experience with performing dissolution and HPLC experiments, method development and/or method validation.
• Understands cGMP and has experience working in a GMP-compliant laboratory. • Must be self motivated, possess good interpersonal skills, able to handle a wide variety of work assignments and able to meet tight timelines. • Has good judgment and awareness to recognize and solve laboratory/data issues to assure high quality data.
• Exhibits good writing skills and is proficient in Microsoft Word, Excel, Outlook, and similar programs.
• Able and willing to work in a team environment and participate in team activities.

Education Required:

BS or MS Degree in Chemistry or related field. We appreciate your interest; however, only candidates selected for an interview will be contacted.

EEO/M/F/D/V

Patheon Pharmaceuticals is seeking a Chemical Control Evening Shift Chemist for our Cincinnati, OH office.  This position is responsible for performing chemical and physical testing following approved methodology, to ensure that the potency, purity, safety and stability of products, components and in-process stages are in compliance with approved chemical specifications.  

Duties and Responsibilities:

Candidates for this position will perform chemical, chromatographic (HPLC & GC), dissolution and other tests specific to the industry, utilizing the latest instrumentation. Must have strong problem-solving skills to recognize and solve laboratory/data issues to assure high quality data, good organizational skills, documentation skills, and the ability to multitask. Position has potential for technical and leadership advancement.  Job level will be dependent on qualifications.

Requirements:

• BS or BA in Chemistry or Biochemistry
• 0-10 years of relevant experience
• Prior pharmaceutical analysis experience a plus
• Good verbal and written communication skills
• Strong analytical techniques and problem solving skills
• Experience with and knowledge of cGMPs a plus.

Interested local candidates should apply online (other resume submissions will not be accepted or considered valid).  Please note that only candidates selected for an interview will be contacted. We are not using agencies at this time.

EEO/M/F/D/V

Duties and Responsibilities:

To manage a section within the Formulation/Process Development department in the development of pharmaceutical formulations for safety and clinical studies, and commercial use.  Supports Director-FD/PD in the management of the department and the PDS business.  Manage the development of pharmaceutical formulations for pre-phase I toxicology and Phase I-IV safety/efficacy clinical trials.  Balance staffing needs vs. project load.  Work with Director to manage department budget requirements.  Ensures that staff fully understands goals and objectives.  Mentors staff.  Ensures that activities/studies are being conducted under appropriate regulatory standards depending on the nature of the activity.  Full responsibility for the development of robust formulations, preparation processes, data interpretation, report preparation, and transfer of technology, via process validation, to Operations.  Oversees the design of product development plans.  Takes a lead role in the preparation and review of proposals.  Sits on Project Teams as representative of Formulation & Process Development.  Approval of study protocols and reports which are communicated to the client.  Builds strong working associations with area leaders in the Commercial Operations departments.  Ensure seamless technology transfers through Demonstration and Validation batch preparation project stages to Operations for commercial manufacturing.   Writes/approves project reports in support of client regulatory filings (including CM&C sections) and/or FDA site inspections (PAI’s).  Consult with QA as needed.  Support audits by clients and regulatory agencies.  Assure that facilities, equipment, and procedures are maintained and established to carryout departmental functions. 

Requirements:

The position requires little guidance in the day-to-day departmental activities.  Directional consistency as per the PDS division is maintained in association with the Director, Formulation/Process Development department.   This position requires the adherence to departmental budgets.  This requirement is critical in meeting PDS division financial objectives.  This position requires a high degree of technical expertise in all phases of formulation/process development.  It requires the continuing evaluation of priorities, resources, project direction, creativity in application of scientific principles to solving technical challenges.  Motivation of people within the department and influencing individuals outside the organization to provide their support and expertise.  Keeping clients informed and satisfied.  Candidates must have experience working in a fast paced pharmaceutical environment requiring high quality results, as well as excellent oral and written communication skills.

Required Education:

Ph.D. in Pharmaceutics/Pharmaceutical Technology (or directly related discipline) with 8+ years of successful experience in pharmaceutical oral solid dosage form development with emphasis on sustained/controlled release, at least 3-4 years in a management role. MS in Pharmaceutics/Pharmaceutical Technology (or directly related discipline) with 12+ years of successful experience in pharmaceutical oral solid dosage form development with emphasis on sustained/controlled release, at least 5-7 years in a management role.

We appreciate your interest; however, only candidates selected for an interview will be contacted.

EEO/M/F/D/V

Patheon Pharmaceuticals is seeking a Manufacturing Leader for our Cincinnati, OH office.

Duties and Responsibilities: 

Coordinate and execute production schedule for manufacturing in the Granulation, Compressing, Coating and Inspection/Printing/Laser areas on the Front of Week - Nights shift.  Supervise, direct and lead approximately 25-30 associates.  Administer all company policies with respect to GMPs, validation, quality, safety, health, attendance, and environment.  With QA, make quality decisions regarding batches in each manufacturing area.  Develop associates and coordinate training on new equipment.  Improve quality of processes as well as identify safety and efficiency improvements.

Requirements:

Applicant should have good working knowledge and understanding of GMPs related to dry products manufacturing.  Working knowledge of BPRs, processes, and equipment in all manufacturing areas is required.  Must have demonstrated the ability to motivate, influence and develop team members.  Must have demonstrated ability to solve problems and make decisions independently.  Must work and communicate well with associates in multiple areas.  Must have demonstrated verbal and written communication skills.   Working knowledge of APACS, PMX, SAP, Outlook, Excel and Word is highly desirable.   Prior experience in supervision or other leadership role is preferred.  History of success in prior positions is required.

Desired Education:

Bachelor’s degree in business, engineering, science, or pharmacy is required.

We appreciate your interest; however, only candidates selected for an interview will be contacted.

EEO/M/F/D/V

Patheon is seeking experienced Manufacturing Operators for all Production shifts.  Candidates should have prior Pharmaceutical experience in Coating, Compressing / Encapsulation and / or Granulation.  Operators will prepare manufacturing areas and assembling equipment for the production of pharmaceutical products, process/manufacture products in accordance with batch records and clean processing equipment and rooms in accordance with written Standard Operating Procedures (SOPs) and established Good Manufacturing Practices (cGMPS) including general housekeeping of manufacturing areas.   Operators must also effectively troubleshoot equipment, and ensure that product quality meets the standards of Patheon, our clients, and applicable regulatory agencies at all times.   In addition to prior Pharmaceutical experience, applicants must have strong math and reading skills, good documentation skills, strong mechanical aptitude, and the ability to lift up to 75 lbs frequently throughout a shift.  

Interested local candidates should apply online (other resume submissions will not be accepted or considered valid).  Please note that only candidates selected for an interview will be contacted. We are not using agencies at this time.  EEO/M/F/D/V

Duties and Responsibilities:

Provides technical support to the daily operation of the Packaging and Liquids Manufacturing Departments.  Leads continuous improvement efforts to optimize equipment operation, minimize equipment-related batch deviations, and maximize changeover and run efficiency of Packaging and Liquids Manufacturing equipment.  Leads/supervises the Packaging mechanical & electrical technicians.  Leads training and development plans to provide Packaging mechanics and electrical technicians with capabilities to properly maintain equipment. Incumbent is responsible for supporting corrective maintenance and improving predictive/preventive maintenance practices.  Responsible for ensuring adequate spare parts inventory is maintained to minimize down time of equipment.  Analyzes equipment histories and develops engineering solutions to eliminate repetitive repairs/failures and equipment caused batch deviations.  Benchmarks best practices and provides technical support to Area Leaders to achieve department first time quality and schedule attainment goals.                                                                                   

Requirements: 

Minimum of 2-5 years experience in pharmaceutical manufacturing, packaging, engineering, scheduling or supervision.  The incumbent must have mechanical and electrical technical aptitude and working experience with maintenance practices and technologies; technical problem solving skills; utilizing resources effectively; proactive approach to problem solving; working knowledge of cGMPs; and writing/executing IQ/OQ/PQ and other associated validation documents.  Position requires ability to scope work, prioritize, schedule and assign tasks to meet customer needs.  Position requires organization, project management, and time management skills to be successful in managing multiple projects and changing priorities.  Good oral and written communication skills.  Good presentation skills with the ability to sell ideas and teach/train others.

Desired Education:

B.S. in Mechanical, Chemical or related Engineering discipline.

 EEO/M/F/D/V 

Patheon Pharmaceuticals is seeking a Packaging Equipment Engineer for our Cincinnati, OH office.

Duties and Responsibilities:

Investigates new, or make modifications to, packaging equipment and related processes that will meet or exceed packaging, client, regulatory, safety, and quality requirements.  Work on client and internal projects, provide recommendations on project options, and lead the implementation of the selected option within established budget, documentation, and timing requirements.  Provide project technical support to Package Engineering team members, internal departments and clients. Assist in the maintenance of departmental technical documents and procedures.  Prepare and execute equipment installations and qualifications as well as prepare equipment specifications and perform factory acceptance tests.  Provides technical support to the daily operation of the Packaging Department.  Leads continuous improvement efforts to optimize equipment operation, minimize equipment-related batch deviations, and maximize changeover and run efficiency of packaging equipment. 

Requirements: 

Approximately 2-5 years experience as an equipment engineer with knowledge of liquid and solid dosage primary filling and secondary packaging operations.  The incumbent must have mechanical and electrical aptitude, technical problem solving skills, working knowledge of cGMPs, and experience writing/executing IQ/OQ/PQ and other associated validation documents.  Project work involves bottle, blister (form, fill, and seal), and cartoning packaging operations.  Experience in project management and cost estimating required.  Good oral and written communication skills.  Good presentation skills with the ability to sell ideas to internal customers and external clients. 

Desired Education:

B.S. in Packaging, Mechanical, or related Engineering discipline.

We appreciate your interest; however, only candidates selected for an interview will be contacted.

EEO/M/F/D/V

Duties and Responsibilities:

Plans, coordinates, and controls assigned finished goods and semi-finished goods product,  raw and package materials, and workflow to achieve high Client Service levels, lowest inventory investment, and highest plant efficiency. Uses SAP planning system, Taylor Shop Floor scheduling system, spreadsheet applications, make-to-order planning techniques/knowledge, and professional direct to client communications to achieve results. This position is responsible for developing production plan/scheules for Manufacturing and Packaging areas; coordinating  material requirements with Purchasing Dept; and coordinating product Purchase Orders with Clients. Acts as Planning dept focal point for transfering products from PDS to Commercial; and for product launch activities.  Initiates and maintains SAP data accuracy for assigned materials, along with SOR data. Works with crossfunctional areas of the site as well as the Client to achieve expected results.   

Requirements:

• Bachelor of Science, Business, Materials Management, Supply Chain or related field
• APICS certification preferred.
• At least 2 years Production Planning, Scheduling & Inventory Management experience required. Pharmaceutical or related business preferred.
• Strong SAP system knowledge required
• Strong spreadsheet experience with emphasis on planning/coordination/accounting techniques.
•  Must be customer focused, have abilities to resolve conflict, good communication skills, is action oriented and a team player

Interested local candidates should apply online (other resume submissions will not be accepted or considered valid).  Please note that only candidates selected for an interview will be contacted. We are not using agencies at this time.

EEO/M/F/D/V

Duties and Responsibilities:

This is a multi-functional position supporting pharmaceutical manufacturing operations in Production Manufacturing Unit.  A successful candidate should have a broad-based background in pharmaceutical manufacturing with a combination of experience and skills in one or more of the following areas:  product/process development, production support, engineering, validation or quality assurance. Strong written and verbal communication as well as project management skills are essential as the position requires interaction and collaboration with the Patheon PDS (Research) organization, outside clients, other supervisory/technical staff and shop floor associates.

This position will focus on leading new product opportunities including transition between development and operations, scale-up, validation and commercial launch activities while maintaining a high level of focus on process safety and product quality. The responsibilities of this position will also include investigating and implementing improvements to existing manufacturing processes concentrating in areas of equipment and processing, trouble shooting of processing difficulties, supporting equipment qualification, introducing new technologies to the manufacturing area, cleaning validation and supporting continuous improvement initiatives. The successful candidate must be flexible with respect to diversified assignments. 

Requirements:

A minimum of 3 - 5 years of experience in the pharmaceutical manufacturing environment is desired.  Broad knowledge of pharmaceutical manufacturing processes, pharmaceutical development and engineering principles is required. A thorough knowledge of cGMPs, SOPs, regulatory compliance, equipment qualification and process validation protocols is also a requirement.  Periodic travel may be required to support projects.

Desired Education:

BS degree in pharmacy, engineering or other related technical discipline is required.

Duties and Responsibilities:

• Coordinate interactions between the client and the internal Patheon team
• Lead the internal Patheon project team
• Schedule and chair all client teleconferences, meetings and visits; including providing project updates to the internal team and to the client
• Monitor and oversee Project Budget and Timelines
• Maintain the PDS project plan over the life of the project
• Provide periodic reports to PDS Management on the status of projects; new developments and opportunities that may arise
• Manage client expectations and issues

Requirements:

• Must be able to provide leadership and direction to the project team
• Must be able to solve problems / make decisions in critical situations
• At least 7 years of industry experience with 2-3 years in Pharmaceutical Product Development (preferred)
• Well organized and detail oriented
• Ability to prioritize multiple tasks
• Strong interpersonal and communication skills, as well as the ability to motivate

Desired Education:

Minimum BS ( MBA desirable) and Industry Experience (Analytical, QA, Regulatory, or Manufacturing) We appreciate your interest; however, only candidates selected for an interview will be contacted. EEO/M/F/D/V

Job Duties and Responsibilities:

Perform chemical and physical testing following approved methodology, to assure that the potency, purity, safety and stability of products, components and in-process stages are in compliance with approved chemical specifications.  Job level will be dependent on qualifications.

Requirements:

Minimum of 0-5 years of lab experience.  Good verbal and written communication skills, analytical techniques and problem solving skills.  Experience with and knowledge of GMPs a plus.

Desired Education:

Applicants should have an associate or bachelor degree or equivalent education in life sciences with an emphasis in chemistry or a closely related discipline.

Interested local candidates should apply online.  We appreciate your interest; however, only candidates selected for an interview will be contacted. We are not using agencies at this time.

EEO/M/F/D/V

Duties and Responsibilities:

The incumbent is responsible for providing SAP FI-CO support and developing enhancements for two separate SAP instances. One is a recently implemented SAP ECC6 Global instance currently being used by our Canadian sites (Toronto, Whitby, and Burlington) and the other is our SAP V4.6c instance being used by our Cincinnati site. Includes support of GL, AP, AR, Cost Center Accounting, Profit Center Accounting, Product Cost Accounting, Fixed Assets, Assessments, etc.  Specific duties:

• Provide support to projects, and tasks related to SAP, with the guidelines and processes established by the SAP Center of Excellence and IT (including SAP configuration) to meet business requirements.
• Leads team to solve complex tasks or complete projects that involve changes and/or enhancements required by the business.  It includes elaboration and coordination of deliverables such as functional and technical specifications, test scripts, SAP configuration and others as assigned.
• Support the IT Manager in fulfilling the Project Management Office (PMO) standards for project execution. Includes coordination of status reports, risk management, etc.
• Coordinate meetings with business as required to provide guidance and define business requirements and requested changes.  This includes end user/team training on IT processes and SAP

Requirements:

• Must have configuration experience and ABAP experience.
• Must be certified in SAP Financial Accounting (FI) and/or Controlling (CO)
• Additional knowledge related to other SAP modules
• Database knowledge with ERP systems (Oracle and SQL) preferred
• Analytical and problem solving skills
• Excellent communication and interpersonal skills to deal effectively with users
• Dedicated and self motivated person who can interact effectively with all levels of the organization
• Ability to learn quickly in a challenging environment
• Strong organizational skills
• Ability to travel between sites as required to provide support
• Proficient use of the English language
• Leadership qualities to provide guidance and support to solve complex tasks
• Experience in developing reports using crystal preferred
• Familiarity with Good Manufacturing Practices
• Familiarity with Computer Validation requirements

Desired Education:

BA or BS degree in Information Technology or equivalent with minimum 3 years of SAP FICO work experience.  PMI, CPIM or CPA certification preferred

We appreciate your interest; however, only candidates selected for an interview will be contacted.  Candidates should apply online (other resume submissions will not be accepted or considered valid). We are not using agencies at this time.

EEO/M/F/D/V

Duties and Responsibilities:

Develop Liquid fill hard shell capsules (LFHC) and Soft gel formulations for pre-phase I toxicology and Phase I-IV safety/efficacy clinical trials. Take an active part in preparation of product batches for feasibility, CTM, and small-volume commercial products. Insure the development of robust formulations, preparation processes, data interpretation, report preparation, and transfer of technology, via process validation to Operations. Prepare study protocols and reports which are communicated to the client. Conduct all activities/ studies under appropriate safety, cGMP and regulatory standards depending on the nature of the activity.

Requirements:

• Ability to lead formulation and production activities independently for concurrent projects.
• Communicate and coordinate with multiple clients.
• Multi-task and plan to meet deadlines in a constantly changing environment.
• Work within time and material constraints to meet or exceed project goals • Direct activities of technical associates
• Proven ability to develop new patented technologies

Education Required:

Ph.D. in Pharmaceutics/Pharmaceutical Technology (or directly related discipline) with 4-8 years of successful experience in pharmaceutical oral dosage form development. MS in Pharmaceutics/ Pharmaceutical Technology (or directly related discipline) with 8-12 years of successful experience in pharmaceutical oral dosage form development. Experience in two-piece hard shell liquid fill capsule and/or softgel dosage forms required.

We appreciate your interest; however, only candidates selected for an interview will be contacted.

EEO/M/F/D/V