• Staff Accountant
• PDM Scientist
• PDM Associate
• Director, Manufacturing

Reports To:             Vice President, Finance

Department:             Finance

 

Job Summary:

General financial / accounting duties, customer billing and accounts receivables, working with business development and project lead to make sure clients are billed timely, contact customer for issues related to invoice and payment, preparing financial report, and assist management for special project.

Essential Duties/Responsibilities:

1. Keep the executed proposal in file (both paper and electronic), understand the contract terms, revenue recognition rules, especially the job activities and payment milestones.
2. Join in the project meeting, follow the project schedule, track the project progress.
3. Billing customer by each milestone after confirming the activity is completed and backup document is received.
4. Save the invoice along with backups in Finance drive.
5. Issue monthly statement of accounts to customers.
6. Keep the customer payment log update when payment is received.
7. Process and prepare financial reports requested.
8. Assist in financial audit and government audit.
9. Bookkeeping, entering vendor invoices for timely payments to include discounts.
10. Assign each transaction on purchase requisition to appropriate GL code.
11. Follow instruction and perform other duties as management requested.

The above reflect the general tasks, duties, activities and/or responsibilities necessary to describe this position and is not intended to set forth all the specific requirements of this position. These job duties/responsibilities may change or vary in response to business needs.

Experience:

Full understanding of whole cycle of accounting including AR, AP, GL and FS preparation.

2+ experience in customer billing, accounts receivable and collection of past due balance.

Pharmaceutical CMO/CRO manufacturing industry experience is preferred.

Billing Federal Government Contract experience is a plus.

Budgeting experience is a plus.

IFRS experience is a plus.

Skills:

QuickBooks and MS Excel.

Skilled and motivated Accountant.

Critical thinking, attention to detail and accuracy is a must.

Education:

Bachelor’s Degree in Accounting.

Job Type: Full-time.

IRISYS, LLC is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. IRISYS does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.

To Apply: If you are interested in being part of the IRISYS LLC team, please email your CV and Cover Letter directly to HR@irisys.com. Please put the job reference “Staff Accountant” in the subject line of the email.

Reports To:             Vice President, Product Development

Department:             Pharmaceutical Development and Manufacturing (PDM)

 

Job Summary:

A Pharmaceutical Development and Manufacturing Scientist is responsible for directing and coordinating all aspects of product development projects, applying scientific method to complex problems of pre-formulation, formulation development, and dosage form manufacturing.

Essential Duties/Responsibilities:

1. Design and conduct experiments for the formulation development of new drug products using novel drug delivery systems, including but not limited to injectables, creams and oral liquids.
2. Design studies write experimental protocols and review all analytical data from trial experiments. Execute and interpret formulation development based on the defined deliverables, planning the activities to meet the project timelines.
3. Involves communication with the clients regarding the project goals and strategic directions.
4. Assume responsibility for developing robust, scalable formulations and processes to produce small cGMP batches for human clinical studies.
5. Utilize prior research background in pharmaceutics and pharmacokinetics to predict the in-vivo performance of dosage form.
6. Performs various editorial duties; writes, reviews and edits various batch records, specifications, scientific reports.
7. Remain current in the field by review of relevant scientific literature.

Primary job responsibilities:

• Project leader for multiple active PDM projects
  • Responsible for formulation development, generating reports for all experiments conducted related to the project.
  • Preparation of small-scale PDM batches.
  • Creation of all documents needed for production: batch records, material specifications, product specifications, label specifications.
  • Communication with clients on a regular basis to ensure that all their requirements are met.
  • Primarily involved in the entire manufacturing process: formulation, filling, visual inspection, labeling, packaging.
  • Resolving any product quality issues arising during the manufacturing process. Issues might be addressed by creation of deviations and CAPA’s.
  • Communicating with Quality Control Department regarding the analytical method development and creation of test specifications.
  • Creating and executing IQ/OQ/PQ for the equipment needed for production.
  • Shipping of finished products to the clients.
• Supervisor of PDM Associate
  • Assigning project related tasks to PDM Associate. Providing them with timelines for completion of set activities.
  • Training on all project related activities. Training includes gowning, manufacturing, equipment related training.
  • Monitor employee productivity and provide constructive feedback and coaching.
• Aseptic rooms maintenance
  • Overseeing all injectable operations, including scheduling of all aseptic projects, preparation of schedules for all personnel working in the aseptic rooms, training employees on aseptic practices.
  • Generation of all aseptic rooms’ qualification protocols. Ensure execution of protocols in the frequency mentioned. review of all results provided and preparing a final report.
  • Primarily responsible for addressing any CAPA’s, deviation’s generated for these rooms.
  • Working closely with the Microbiology team to schedule environmental monitoring for the aseptic rooms. Actively involved in any issues which arise during EM and any OOS which is generated.
  • Helped establish the Facility maintenance program. Participate in the weekly Facility maintenance meeting to discuss any issues related to Facility. Provide optimal solutions to problems and follow-up on implementation of solutions.
• Authoring of proposals
  • Generating change orders and proposals for existing PDM projects as per client needs.
  • Creation of proposals in response to the “Request for Proposal” (RFP) provided by Government agencies or clients.
• Non-aseptic rooms maintenance
  • Generation of all non-aseptic rooms’ qualification protocols. Ensure execution of protocols in the frequency mentioned. review of all results provided and preparing a final report.
• Coordination and scheduling of external contractors
  • Primarily responsible for scheduling of external contractors for all cleaning activities for the aseptic rooms.
• Supporting Quality Assurance
  • Assist in drafting of responses to any audit related observations. Providing viable solutions to audit observations and working towards implementation of these solutions.
• Drafting and modification of SOP’s
  • Authoring SOP’s for project related equipment and processes.
  • Revising equipment SOP’s as part of the Preventive Maintenance Program.
  • Authoring most of the SOP’s related to aseptic manufacturing.

The above reflect the general tasks, duties, activities and/or responsibilities necessary to describe this position and is not intended to set forth all the specific requirements of this position. These job duties/responsibilities may change or vary in response to business needs.

Experience/Skills:

Advanced computer and verbal communication skills.

Experience working in GMP environment.

Hands-on experience in the preparation and analysis of small molecule and/or protein formulations and stability studies.

Experience with formulation ingredient regulations for cosmetic and food industries is a plus.

Education:

Bachelor’s degree required in Chemistry, Biochemistry, Pharmaceutical Science, Formulation Science, Chemical Engineering with 5 years of experience; MS with 2 years of experience or Ph. D. preferred.

Job Type: Full-time.

IRISYS, LLC is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. IRISYS does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.

To Apply: If you are interested in being part of the IRISYS LLC team, please email your CV and Cover Letter directly to HR@irisys.com. Please put the job reference “PDM Scientist” in the subject line of the email.

Reports To:             Group Leaders

Department:             Pharmaceutical Development and Manufacturing (PDM)

 

Job Summary:

PDM Associate will work under general direction, assisting the research investigators by performing moderately complex research and experimentation following established protocols.

Essential Duties/Responsibilities:

1. Perform cGMP manufacturing of Sterile and Non-sterile dosage forms.
2. Responsible for ordering GMP and PDM supplies for manufacturing campaigns and GLP studies.
3. Work with Quality departments (QC and QA) to maintain Manufacturing project goals and timelines.
4. Responsible for set-up of Production suites as per IRISYS _LLC
5. Perform various editorial duties; writes, reviews and edits SOP’s, Batch records and Material specifications.
6. Create and Execute Qualification Protocols for new equipment at IRISYS
7. Sets-up and operates various scientific apparatus, such as centrifuges, mixers, lyophilizers, incubators, homogenizers, tablet press, capsule filling machine.
8. Perform and analyze data generated by analytical methods such as HPLC and Particle Size analyzer.
9. Assist Scientists/Group Leaders with research projects.

The above statements reflect the general tasks, duties, activities and/or responsibilities necessary to describe this position and is not intended to set forth all of the specific requirements of the job. These job duties/responsibilities may change or vary in response to business needs.

Experience:

2+ years in the Pharmaceutical or Health science sector.

Experience with cGMP manufacturing is highly preferred.

Experience with or some knowledge of pharmaceutical Research, Development and Manufacturing unit processes (e.g., powder granulations, powder blending, tablet compression, encapsulation, aseptic mix and fill procedures, microencapsulation, etc.) is desirable.

Education:

A qualified candidate for the position must have at a minimum bachelor’s degree in Chemistry, Biochemistry, Physical Chemistry or other related field.

Knowledge, Skills and/or Abilities:

Familiarity with cGMP/FDA regulations.

Knowledge of laboratory procedures, of the use and preparation of solution, chemicals, and reagents.

Verbal and written communication skills.

Ability to follow oral and written instructions, to tend to details, to maintain records and inventory.

Job Type: Full-time

IRISYS, LLC is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. IRISYS does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.

To Apply: If you are interested in being part of the IRISYS LLC team, please email your CV and Cover Letter directly to HR@irisys.com. Please put the job reference “PDM Associate” in the subject line of the email.

Reports To:             President and Chief Scientific & Technical Officer

Department:             Manufacturing

 

Job Summary:

IRISYS serves as the Research & Development, manufacturing, regulatory and strategic partner for innovative pharma companies, and the National Institutes of Health as they move compounds from early research through the clinical trials required for regulatory approvals. IRISYS also manufactures, under contract prescription and OTC pharmaceuticals.

The Director of Manufacturing is responsible for driving quality, efficiency, and leading the expansion of our company’s pharmaceutical formulations manufacturing department. The successful candidate will have a strong record of accomplishments and successful leadership experience in drug development, clinical trial material manufacturing, Quality Assurance, and commercial drug product manufacturing, preferably with experience in a pharma company that has scaled from early-stage pre-formulation studies to qualification, validation and commercial production. Experience with sterile product manufacturing in addition to oral solids is a plus.

Essential Duties/Responsibilities:

1. Coordinating with all departments and leading department to complete scale -up, validation, launch and routine manufacturing of oral dosage forms and sterile products.

• Product and process validation protocol development, execution, and reporting.
• Cleaning validation protocol development, execution, and reporting.
• New equipment IQ/OQ/PQ (protocol development, execution, reporting).

2. Oversight of the creation and maintenance of production schedules with the assistance of the Manufacturing Supervisor(s) and concurrence of the management group.

• Scheduling and Supervision of Manufacturing Supervisors.
• Oversight of Manufacturing Supervisors in the final review of batch documentation.
• In cooperation with Manufacturing Supervisor(s) and Manufacturing Associates, ensures proper maintenance of all manufacturing equipment.
• Training of Manufacturing Supervisors and Manufacturing Associates.
• Oversight of inventory control to the extent that the Director of Manufacturing will be responsible for the receiving process for raw materials and will interact with the Manufacturing Supervisors, Purchasing Group, Controller, and QC/QA to ensure that materials are available as needed.
• Coordinates activities with outside suppliers and consultants to ensure the delivery of supplies or services needed to meet scheduled timelines.

3. Demonstrates commitment to the development, implementation, and effectiveness of Quality Management System per cGMP company wide in close cooperation with QA. Takes responsibility for:

• General training
• SOP writing
• Equipment maintenance and calibration

4. Responsible for quoting and establishing feasibility for new business opportunities including new product cost analysis. Participate with Senior management in the development of new business Contract Manufacturing.
5. Assume responsibility for the validation, maintenance, and operation of sterile filling and lyophilization line.
6. Contributes new ideas for internal product development.

The above statements reflect the general tasks, duties, activities and/or responsibilities necessary to describe this position and is not intended to set forth all of the specific requirements of the job. These job duties/responsibilities may change or vary in response to business needs.

Education:

Bachelor’s degree required in Engineering (Mechanical, Chemical or Manufacturing), Chemistry, Biochemistry, or related scientific field. Advanced degree preferred. Experience in lieu of higher degree will be considered.

Experience/Skills:

10+ years leading a GMP manufacturing environment (Staff development, production planning, compliance, mfg. process cost improvement, safety, and cost control).

3+ years of project management experience is desired.

7+ years of supervisory experience; coaching, mentoring, and training staff at all levels.

Working experience with capacity modeling, process mapping, Lean/Six Sigma, and value stream mapping.

Experience in working with manufacturing-based technology, processes and knowledge of Environmental Health and Safety practices is preferred.

Excellent communication skills, both written and verbal.

Job Type: Full-time

IRISYS, LLC is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. IRISYS does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.

To Apply: If you are interested in being part of the IRISYS LLC team, please email your CV and Cover Letter directly to HR@irisys.com. Please put the job reference “Director of Manufacturing” in the subject line of the email.